Annual Comprehensive List of Guidance Documents at the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998N-0046]

Annual Comprehensive List of Guidance Documents at the Food and Drug Administration

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.

DATES:

We welcome general comments on this list and on agency guidance documents at any time.

ADDRESSES:

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to

http://www.fda.gov/dockets/ecomments

. For information on a specific guidance or to obtain a hard copy of any of the guidances currently in use, contact the appropriate Center listed in the

SUPPLEMENTARY INFORMATION

section of this document.

FOR FURTHER INFORMATION CONTACT:

Regarding GGPs: Lisa Helmanis, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

FDA's GGPs were published in the

Federal Register

of September 19, 2000 (65 FR 56468), and became effective October 19, 2000. GGPs (§ 10.115 (21 CFR 10.115)) are intended to ensure involvement of the public in the development of guidance documents, and to enhance understanding of the availability, nature, and legal effect of such guidance. In § 10.115(n)(2), FDA stated that it intended to publish an annual comprehensive list of guidance documents. The list in this document updates a comprehensive list that published January 5, 2005 (70 FR 824).

This year FDA has adopted a new format for its annual comprehensive guidance list. This new format is intended to increase the timeliness of the annual comprehensive list. For information on a specific guidance or to obtain a hard copy, please refer to the heading of each Center's section (sections II through VIII of this document). The list of guidance documents that have been withdrawn is for those guidances that have been withdrawn from January 5, 2005, to January 5, 2006. The list of current guidance documents is a printout of FDA's Web site as of January 31, 2006 or February 1, 2006. You are encouraged to use FDA's Web site as the most up-to-date source for all current guidance documents in use by the agency, as the Web site is updated on a daily basis.

In accordance with the agency's general policy on guidances, you may comment on this list and on any FDA guidance document at any time.

We have organized the documents by the issuing Center or Office within FDA. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing Center or Office maintains its own database, there are slight variations in the way in which they provide the information in this document.

II. Center for Biologics Evaluation and Research (CBER)

For information on a specific guidance document or to obtain a hard copy, contact: Office of Communication, Training, and Manufacturers Assistance, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800,

http://www.fda.gov/cber/guidelines.htm

.

The following is a list of CBER guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

Title of Document

Date of Issuance

Date of Withdrawal

Draft Guideline for the Validation of Blood Establishment Computer Systems

9/28/1993

3/9/2005

Draft Guidance for Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments

8/3/2001

6/28/2005

Guidance for Industry: Discontinuation of Donor Referral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection

5/6/2005

6/30/2005

The following is a copy of the list of current CBER guidance documents obtained from the FDA Web site on March 14, 2006.

CBER Guidance Documents (obtained from the FDA Web site on March 14, 2006)

2006

Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines—3/2/2006

Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines—3/2/2006

FDA Initiative Helps Expedite Development of Seasonal and Pandemic Flu Vaccines—3/2/2006

Guidance for Industry: Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997—2/15/2006

Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications—2/13/2006

Draft Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims—2/2/2006

Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format—1/18/2006

Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format—1/18/2006

Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format—1/18/2006

Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements—1/18/2006

Draft Guidance for Industry: INDs—Approaches to Complying with CGMP During Phase 1—1/12/2006

Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP—1/11/2006

Guidance for Industry: Fast Track Drug Development Programs—Designation, Development, and Application Review—1/11/2006

Appendix 2

Appendix 3—CDER MAPP 6020.3, CBER SOPP 8405

Appendix 4

2005

Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees—12/30/2005

FEDERAL REGISTER: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees—12/30/3005

Draft Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency—11/30/2005

Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—11/30/2005

Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies—10/19/2005

International Conference on Harmonisation (ICH); Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs—10/19/2005

International Conference on Harmonisation (ICH); Guidance for Industry: S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals—10/19/2005

Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications—10/18/2005

International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD—10/18/2005

Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended—Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices—10/7/2005

Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002—Identification of Manufacturer of Medical Devices—6/19/2003

Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods—9/30/2005

International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports—9/30/2005

Draft Guidance for Industry: Using Electronic Means to Distribute Certain Product Information—9/29/2005

Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials—9/19/2005

Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002—9/15/2005

Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act—9/7/2005

International Conference on Harmonisation (ICH); Draft Guideline: M5 Data Elements and Standards for Drug Dictionaries—9/2/2005

Draft Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events—8/23/2005

International Conference on Harmonisation (ICH); Draft Consensus Guideline: Q9 Quality Risk Management—8/5/2005

Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry—7/19/2005

Draft Guidance: Emergency Use Authorization of Medical Products—7/5/2005

FEDERAL REGISTER: Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection; Withdrawal of Guidance—6/30/2005

International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process—6/29/2005

FEDERAL REGISTER: Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance—6/28/2005

Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection—6/23/2005

Draft Guidance for Industry: Bar Code Label Requirements—Questions and Answers—6/7/2005

Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients—5/18/2005

Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices—5/12/2005

Draft Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials—4/29/2005

Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies—4/27/2005

Guidance for Industry and FDA Staff: Application User Fees for Combination Products—4/20/2005

Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Content of Labeling—4/20/2005

Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product—4/11/2005

Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics—4/1/2005

International Conference on Harmonisation (ICH); Guidance for Industry: E2E Pharmacovigilance Planning—3/31/2005

Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products—3/30/2005

Guidance for Industry: Premarketing Risk Assessment—3/25/2005

Guidance for Industry: Development and Use of Risk Minimization Action Plans—3/25/2005

Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment—3/25/2005

Draft Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials—3/25/2005

Guidance for Industry: Pharmacogenomic Data Submissions—3/22/2005

Attachment to Guidance on Pharmacogenomic Data Submissions—3/22/2005

International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests—3/11/2005

Companion Document: Current Q&As and Change Requests—3/11/2005—Updated—7/18/2005—Updated—1/6/2006

International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification—4/1/2003

International Conference on Harmonisation (ICH) Guidance for Industry: E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 2)—3/9/2005

FEDERAL REGISTER: Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance—3/9/2005

Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle—3/9/2005

Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms—2/23/2005

Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications—2/17/2005

Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications—12/27/1996

FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration; Correction—2/11/2005

FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration—1/5/2005

International Conference on Harmonisation (ICH); Draft Guidance on Q8 Pharmaceutical Development—2/8/2005

Draft Guidance for Industry: Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling—2/7/2005

International Conference on Harmonisation (ICH); Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals—2/7/2005

Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees—1/3/2005

2004

International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD—Efficacy: Questions and Answers (Revision 3)—12/22/2004

International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD—General: Questions and Answers (Revision 3)—12/22/2004

Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use—11/30/2004

Guidance for Industry: Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992; Notice of extension of application deadline—11/19/2004

Guidance for Industry: Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA—10/6/2003

Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA—11/17/2004

Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—11/12/2004

Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)—11/8/2004

Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes—10/28/2004

Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV—10/21/2004

Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria—10/1/2004

Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information—10/1/2004

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice—9/29/2004

Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations—9/29/2004

Draft Guidance for Industry and FDA: Current Good Manufacturing Practice for Combination Products—9/29/2004

Draft Guidance for Industry: Computerized Systems Used in Clinical Trials 9/29/2004

Guidance for Industry: Computerized Systems Used in Clinical Trials—5/10/1999

FEDERAL REGISTER—Annual Guidance Agenda—9/23/2004

Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct—9/2/2004

Guidance on Research Involving Coded Private Information or Biological Specimens—8/30/2004

Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification—8/20/2004

Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols—8/18/2004

Guidance for Industry: Available Therapy—7/21/2004

Guidance for Industry: FDA Export Certificates (Corrected to update the Medical Devices contact phone number 4/27/2005)—7/12/2004

International Conference on Harmonisation (ICH); Guidance for Industry: Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV—7/2/2004

Guidance for Industry: Developing Medical Imaging Drug and Biological Products—6/17/2004

Part 1: Conducting Safety Assessments

Part 2: Clinical Indications

Part 3: Design, Analysis, and Interpretation of Clinical Studies

International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD—Quality: Questions and Answers/Location Issues—6/8/2004

International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data—6/7/2004

International Conference on Harmonisation (ICH); Guidance for Industry: E5—Ethnic Factors in the Acceptability of Foreign Clinical Data—Questions and Answers—6/3/2004

Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s)—5/28/2004

Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment—5/20/2004

Draft Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—5/20/2004

Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance

Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components—4/23/2004

Draft Guidance for Industry: Vaccinia Virus—Developing Drugs to Mitigate Complications from Smallpox Vaccination—3/8/2004

International Conference on Harmonisation (ICH); Guidance for Industry: Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs—2/4/2004

International Conference on Harmonisation (ICH); Guidance for Industry: E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs—11/1996

Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices—2/4/2004

Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements—2/4/2004

Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule)—2/4/2004

Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement—2/4/2004

Draft Guidance for Industry: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms—2/4/2004

Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1)—1/26/2004

Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions—3/18/2002

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revision 1)—1/16/2004

Draft Guidance for Industry: Drug Substance—Chemistry, Manufacturing, and Controls Information—1/6/2004

2003

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Human Dura Mater—12/17/2003

Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components—12/09/2003

Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices—11/21/2003

Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications—11/21/2003

Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission—11/21/2003

Guidance for Industry and FDA: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products—3/12/2003

International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products—11/20/2003

International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R) Impurities in New Drug Products—11/13/2003

International Conference on Harmonisation (ICH); Guidance for Industry: Q3C—Tables and List—11/12/2003

Guidance for Industry: Q3C Impurities: Residual Solvents—12/24/1997

Guidance for Industry: Product Recalls, Including Removals and Corrections—10/31/2003

Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review—10/31/2003

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus—10/30/2003

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General Considerations—10/22/2003

Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General Considerations—1/28/1999

Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment—10/8/2003

Guidance for Industry: Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under PDUFA—10/6/2003

Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion—9/22/2003

Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS—9/16/2003

Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS—4/17/2003

Question and Answer on FDA Guidance Entitled “Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS”—Since Publication of this guidance, CDC issued a health alert for travelers arriving from Toronto Canada, and updated their case definition. As discussed in the guidance under section II.B.3., Updated Information on Case Definitions in Areas Affected by SARS, the FDA indicated that you should consult with the CDC website and phone number for updates. Phone (888) 246-2675.

Updated Interim U.S. Case Definition of Severe Acute Respiratory Syndrome (SARS). http://www.cdc.gov/ncidod/sars/casedefinition.htm.

ICH Draft Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting—9/12/2003

Draft Guidance for Industry: Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information—9/3/2003

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application—9/3/2003

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Annual Reports for New Drug Applications and Abbreviated New Drug Applications—8/27/2003

Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)—8/15/2003

Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification—8/1/2003

Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices—7/24/2003

Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires—7/3/2003

Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices—7/3/2003

Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis—6/25/2003

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports—6/23/2003

Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations—6/19/2003

Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling—5/30/2003

Guidance for Industry: Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications—5/5/2003

Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review—5/1/2003

FEDERAL REGISTER—Annual Guidance Agenda—4/4/2003

Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans—4/3/2003

International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification—4/1/2003

International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests—3/11/2005

Companion Document: Current Q&As and Change Requests—3/11/2005—Updated—7/18/2005—Updated—1/6/2006

Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification—3/12/2003

Draft Guidance for Industry; Comparability Protocols—Chemistry, Manufacturing, and Controls Information—2/20/2003

International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances—2/11/2003

Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews—2/3/2003

International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD—Safety: Questions and Answers—2/3/2003

Draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls Information—1/28/2003

International Conference on Harmonisation (ICH); Guidance for Industry; Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products—1/15/2003

Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers—1/15/2003

Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox VaccineRecipients—12/30/2002—(Corrected 2/4/2003)

Questions and Answers on FDA Guidance Entitled “Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients”

2002

The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry—10/3/2002

Guidance for Industry: Establishing Pregnancy Exposure Registries—9/20/2002—

Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals—9/6/2002

Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—6/14/2002

Guidance for Industry: Special Protocol Assessment—5/16/2002

Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers—5/13/2002

Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation—7/7/1999

Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public—5/2/2002—HHS Guideline

Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components and Source Plasma Donations—4/10/2002

Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs)—3/26/2002

Electronic IND Demo

Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation—3/8/2002

Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts—2/1/2002

Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts—12/23/1999

Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff—1/11/2002

Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products—1/9/2002

Questions and Answers on ”Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products”

2001

Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act—11/21/2001

Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees—11/15/2001

Guidance for Industry—Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax—10/17/2001

International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document—10/16/2001—

M4: Organization of the CTD

M4E: The CTD—Efficacy

M4Q: The CTD—Quality

M4S: The CTD—Safety

M4S: The CTD—Safety Appendices

Guidance for Industry: Content and Format of Geriatric Labeling—10/5/2001

Guidance for Industry: Cancer Drug and Biological Products—Clinical Data in Marketing Applications—10/5/2001

International Conference on Harmonisation (ICH) Guidance; Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients—9/25/2001

Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format—General Considerations—9/5/2001

Draft Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls—8/28/2001

Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research—8/22/2001

Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis—8/22/2001

Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments—8/10/2001

Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components—8/10/2001

Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture—8/7/2001

Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers—7/19/2001

Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)—7/19/2001

Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components—7/19/2001

ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals—7/12/2001

Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors—7/11/2001

Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From An Outside Supplier—7/11/2001

Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information—5/25/2001

Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution—5/14/2001

ICH Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials—5/11/2001

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports—5/3/2001

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing—3/29/2001

Guidance for Industry: Financial Disclosure by Clinical Investigators—3/28/2001

Guidance for Industry: Acceptance of Foreign Clinical Studies—3/13/2001

Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines—3/12/2001

Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research—2/15/2001

Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods—Technical Correction February 2001—2/13/2001

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling—1/31/2001

Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion—1/23/2001

PHS Guideline on Infectious Disease Issues in Xenotransplantation—1/19/2001

2000

International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances—12/29/2000

International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population—12/15/2000

Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))—12/4/2000

Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices—11/22/2000

Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol—11/20/2000

Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts—11/20/2000

Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds—10/26/2000

Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors—10/18/2000

Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products—10/3/2000

Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products—11/1995

Draft Guidance for Industry: Analytical Procedures and Methods Validation—Chemistry, Manufacturing, and Controls Documentation—8/30/2000

Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings—7/22/2000

Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment—6/28/2000

Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens—6/23/2000

Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request—6/21/2000

Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria—6/8/2000

Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components—6/6/2000

Guidance for Industry: United States Industry Consensus Standard for the Uniform labeling of Blood and Blood Components Using ISBT 128—11/1999

Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing—3/15/2000

Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products—3/7/2000

Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level—3/7/2000

International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use—2/10/2000

1999

Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2—12/14/1999

Guidance for Industry: In Vivo Drug Metabolism / Drug Interaction Studies—Study Design, Data Analysis and Recommendations for Dosing and Labeling—11/24/1999

REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format—Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)]—11/12/1999, REVISED 11/22/1999

CBER Computer Assisted License Application (CALA) Questionnaire

Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act—10/8/1999

Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications—9/13/1999

Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products—8/27/1999

ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products—8/18/1999

Guidance for Industry: Consumer-Directed Broadcast Advertisements—8/6/1999

Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics—8/3/1999

Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations—7/24/1999

Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)—7/15/1999

ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability—6/25/1999

Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)—6/17/1999

FEDERAL REGISTER Notice of Availability—6/22/1999

Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV—9/23/1998

Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use—5/20/1999

Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products—5/20/1999

Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use”—5/10/1999

Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test—4/23/1999

Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans—4/6/1999

Draft Guidance for Industry: Accelerated Approval Products—Submission of Promotional Materials—3/26/1999

Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional Labeling—3/12/1999

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product—3/8/1999

Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products—2/17/1999

Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA)—2/17/1999

Guidance for Industry: Population Pharmacokinetics—2/10/1999

Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products—2/3/1999

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product—1/5/1999

1998

Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products—11/30/1998

Guidance for Industry; Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997—10/30/1998

Draft Guidance for Industry: Submitting Debarment Certification Statements—10/2/1998

ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin—9/24/1998

Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV—9/23/1998

ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products—9/21/1998

ICH Guidance on Statistical Principles for Clinical Trials—9/16/1998

Withdrawal of “Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)”—Information Sheet—9/8/1998

Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)—3/20/1998

Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1)—9/8/1998

Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications—7/27/1998

Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements—7/21/1998

Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996—6/12/1998

Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing—6/11/1998

ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data—6/10/1998

Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products—6/8/1998

Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products—5/15/1998

Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements—5/15/1998

Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis and Impact on Dosing and Labeling—5/15/1998

Guidance for Industry: Classifying Resubmissions in Response to Action Letters—5/14/1998

Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research—5/13/1998

Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients—4/17/1998

Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy—3/30/1998

Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products—1/28/1998

Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products—1/8/1998

1997

Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS)—12/1997

Final Guidance on Industry-Supported Scientific and Educational Activities; Notice—12/3/1997

Guidance for FDA and Industry: Direct Final Rule Procedures—11/21/1997

Guidance for Industry: Industry-Supported Scientific and Educational Activities—11/1997

Guidance for Industry—The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use—10/07/1997

Guidance for Industry—Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report—8/27/1997

Guidance for Industry—Donor Screening for Antibodies to HTLV-II—8/15/1997

Guidance for Industry—Screening and Testing of Donors of Human Tissue Intended for Transplantation—7/29/1997

Guidance for Industry—Changes to an Approved Application: Biological Products—7/24/1997

Guidance for Industry—Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products—7/24/1997

International Conference on Harmonisation (ICH) Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology—5/19/1997

International Conference on Harmonisation (ICH) Guidelines for the Photostability Testing of New Drug Substances and Products—5/16/1997

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies—4/10/1997

Proposed Approach to Regulation of Cellular and Tissue-Based Products—2/28/1997

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use—2/28/1997

Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products—1/10/1997

1996

Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use—8/1996

International Conference on Harmonisation: Final Guidance on Stability Testing of Biotechnological / Biological Products—7/10/1996

Guidance for Industry—The Content and Format for Pediatric Use Supplements—5/1996

Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Structural Repair or Reconstruction—5/1996

FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products—4/1996

International Conference on Harmonisation: Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals—3/1996

International Conference on Harmonisation: Final Guideline on Quality of Biotechnical Products: Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products—2/1996

1995 and earlier

Draft Reviewers' Guide: Disease Associated Antibody Collection Program—10/1/1995

Draft Reviewers' Guide: Informed Consent for Plasmapheresis / Immunization—10/1/1995

Guideline for Quality Assurance in Blood Establishments—7/11/1995 (NOTE: The text version does not contain Tables 1-8)

FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of Biological Products—7/11/1995

Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals—1995

Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substance—11/1/1994

Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products—11/1994

Guidance on Alternatives to Lot Release for Licensed Biological Products—7/14/1993

Draft Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993)—7/12/1993

FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics—11/25/1992

Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologics Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability—4/6/1992

Guideline for the Determination of Residual Moisture in Dried Biological Products—1/1/1990

Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (“High Risk” Donors)—10/26/1989

Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononeuclear Leukocytes for Administering to Humans—8/22/1989

Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1—8/8/1989

Revised Guideline for the Collection of Platelets, Pheresis—10/7/1988

Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices—12/1987

Guideline on General Principles of Process Validation—5/1987

Guideline for the Uniform Labeling of Blood and Blood Components—8/1985

Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology—4/10/1985

Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans—7/28/1983

Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances—6/1980

III. Center for Drug Evaluation and Research (CDER)

For information on a specific guidance document or to obtain a hard copy, contact: Division of Drug Information, Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573,

http://www.fda.gov/cder/guidance/index.htm

.

The following is a list of CDER guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

Title of Document

Date of Issuance

Date of Withdrawal

Preclinical Development of Antiviral Drugs

11/1/1990

7/6/2005

Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence

3/9/2000

8/12/2005

Phenytoin/Phenytoin Sodium Capsules, Tablets and Suspension In Vivo Bioequivalence and In Vitro Dissolution Testing

3/4/1994

9/6/2005

Organization of an Abbreviated New Drug Application

3/2/1999

11/18/2005

Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders

9/4/1992

12/29/2005

The following is a copy of a list of current CDER guidance documents obtained from the FDA Web site as of March 14, 2006.

CDER Guidance Documents (obtained from the FDA Web site on March 14, 2006)

FDA's Good Guidance Practices regulation of September 19, 2000.

Comprehensive List of Guidance Documents (updated 2/28/2006)

Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2006 (03/01/2006)

New/Revised/Withdrawn List for 2006 (updated 2/28/2006)

New/Revised/Withdrawn List for 2005 (updated 1/4/2006)

Advertising

Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling (Issued 12/1997, Posted 1/12/1998)

Consumer-Directed Broadcast Advertisements (Issued 8/1999, Posted 8/6/1999)

Questions and Answers (Posted 8/6/1999)

Industry-Supported Scientific and Educational Activities (Issued 12/3/1997, Posted 12/4/1997)

Advertising Draft

Accelerated Approval Products: Submission of Promotional Materials (Posted 3/26/1999)

Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (Posted 2/4/2004)

Labeling Example

Labeling Example; Consumer-Friendly Version

Consumer-Directed Broadcast Advertising of Restricted Devices (Issued 1/26/2004, Posted 2/4/2004)

“Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (Issued 1/26/2004, Posted 2/4/2004)

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (Issued 1/1999, Posted 3/12/1999)

Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs) (Issued 12/1997. Posted 1/5/1998)

Biopharmaceutics

Bioanalytical Method Validation (Issued 5/2001, Posted 5/22/2001)

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (Issued 3/2003, Posted 3/19/2003)

Cholestyramine Powder in Vitro Bioequivalence (Intermin Guidance)

Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 6/17/2005, Posted 6/17/2005)

Corticosteroids, Dermatologic (topical) In Vivo (Issued 6/2/1995, Posted 3/6/1998)

Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posted 8/25/1997)

Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (Issued 9/1997, Posted 9/26/1997)

Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003)

Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (Issued 6/27/1989, Posted 3/2/1998)

Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing (Revised 6/6/1994, Posted 6/22/1998)

Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001)

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. (Issued 8/2000, Posted 8/31/2000)

Biopharmaceutics (Draft)

Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003)

Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data (Posted 4/11/2003)

Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence. Withdrawn per August 12, 2005, Federal Register notice.

CGMPs (Pharmaceutical CGMPs for the 21st Century)

Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Issued 1/11/2006; Posted 1/11/2006)

Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (Posted 8/4/2004)

Part 11, Electronic Records; Electronic Signatures—Scope and Application (Posted 9/3/2003)

PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (posted 9/29/2004)

Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice Posted 9/29/2004

CGMPs (Pharmaceutical CGMPs for the 21st Century)—Draft

Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information (Posted 9/3/2003)

Current Good Manufacturing Practice for Combination Products (Posted 9/29/2004)

INDs—Approaches to Complying with CGMP's for Phase 1 Drugs (Issued 1/12/2006; Posted 1/12/2006)

Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment (Issued 11/2003, Posted 11/6/2003)

Revised Attachments (Issued 11/2003, Posted 11/21/2003)

Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Posted 9/29/2004)

Chemistry

BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation (Issued 2/2001, Posted 2/16/2001)

Botanical Drug Products (Issued 6/2004, Posted 6/9/2004)

Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Issued 7/1997, Posted 7/28/1997)

Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004)

Changes to an Approved NDA or ANDA: Questions and Answers (Issued 1/2001, Posted 1/22/2001)

Changes to an Approved NDA or ANDA; Specifications—Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004)

Container Closure Systems for Packaging Human Drugs and Biologics (Issued 5/1999, Posted 7/6/1999)

Container Closure Systems for Packaging Human Drugs and Biologics—Questions and Answers (Issued 5/2002, Posted 5/10/2002)

Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products

Development of New Stereoisomeric Drugs (5/1/1992) (Post Date: 1/3/1996)

Drug Master Files (9/1/1989)

Current DMF Information (e.g. lists, addresses, guidances, etc.)

Drug Master Files for Bulk Antibiotic Drug Substances (Issued 11/1999, Posted 11/26/1999)

Environmental Assessment of Human Drug and Biologics Applications (Issued 7/1998, Posted 7/24/98)

Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* (Issued 2/1987, Posted 3/2/1998)

Format and Content for the CMC Section of an Annual Report (9/1/1994)

INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (Posted 5/20/2003)

IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (Issued 5/2001, Posted 6/4/2001)

Monoclonal Antibodies Used as Reagents in Drug Manufacturing (Issued 3/2001, Posted 3/28/2001)

Nasal Spray and Inhalation Solution, Suspension, and Drug Products (Issued 7/2002, Posted 7/3/2002)

NDAs: Impurities in Drug Substances (Issued 2/2000, Posted 2/24/2000)

PAC-ATLS: Postapproval Changes—Analytical Testing Laboratory Sites (Issued 4/28/1998, Posted 4/28/1998)

The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) (12/20/2000)

SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation

SUPAC-IR Questions and Answers about SUPAC-IR Guidance (2/18/1997)

SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (Issued 1/1999, Posted 2/25/1999)

SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Issued 10/6/1997, Posted 10/6/1997)

SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/1997; Posted 6/16/1997)

Reviewer Guidance, Validation of Chromatographic Methods

Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products

Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances

Submitting Documentation for the Manufacturing of and Controls for Drug Products* (Issued 2/1987, Posted 3/2/1998)

Submitting Documentation for the Stability of Human Drugs and Biologics* (Issued 2/1987, Posted 3/2/1998)

Submitting Samples and Analytical Data for Methods Validation

Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances

Chemistry (Draft)

Analytical Procedures and Methods Validation. (Issued 8/2000, Posted 8/30/2000)

Comparability Protocols—Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003)

Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Posted 9/11/2003)

Drug Product: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)

Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2004, Posted 1/6/2004)

Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (7/24/1999)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (Issued 11/13/1998, Posted 11/19/1998, Posted 9/27/1999)

Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. (Issued 7/2002, Posted 8/20/2002)

Stability Testing of Drug Substances and Drug Products (Issued 6/5/1998, Posted 6/8/1998)

SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (Issued 12/1998, Posted 1/5/1999)

Clinical/Antimicrobial

Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval (Issued 10/2002, Posted 10/31/2002)

Clinical Development and Labeling of Anti-Infective Drug Products (Issued 10/1992, Posted 3/2/1998, Revised 2/12/2001)

Clinical Evaluation of Anti-Infective Drugs (Systemic) (Issued 9/77, Posted 3/2/1998)

Clinical/Antimicrobial (Draft)

Acute Bacterial Exacerbation of Chronic Bronchitis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Acute Bacterial Meningitis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Acute Bacterial Sinusitis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Acute or Chronic Bacterial Prostatitis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Acute Otitis Media—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Antiviral Drug Development—Conducting Virology Studies and Submitting the Data to the Agency (Issued 5/24/2005, Posted 5/24/2005)

Bacterial Vaginosis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for Treatment (Issued 10/1999, Posted 10/18/1999)

Community-Acquired Pneumonia—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Complicated Urinary Tract Infections and Pyelonephritis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Developing Antimicrobial Drugs—General Considerations for Clinical Trials (Issued 7/22/1998, Posted 7/22/1998)

Empiric Therapy of Febrile Neutropenia—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (2/18/1997)

Inhalational Anthrax (Post Exposure)—Developing Antimicrobial Drugs (Issued 3/15/2002, Posted 3/15/2002)

Lyme Disease—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Nosocomial Pneumonia—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (Issued 11/26/04, Posted 11/26/04)

Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Streptococcal Pharyngitis and Tonsillitis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Uncomplicated and Complicated Skin and Skin Structure Infections—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Uncomplicated Urinary Tract Infections—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Vaccinia Virus—Developing Drugs to Mitigate Complications from Smallpox Vaccination (Posted 3/8/2004)

Vulvovaginal Candidiasis—Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)

Clinical/Medical

Acceptance of Foreign Clinical Studies (Posted 3/12/2001)

Available Therapy (Posted 7/22/2004)

Calcium DTPA and Zinc DTPA Drug Products—Submitting a New Drug Application (Posted 8/13/2004)

Cancer Drug and Biological Products—Clinical Data in Marketing Applications (Posted 10/11/2001)

Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (Issued 1/1999, Posted 2/16/1999)

Clinical Development Programs for MDI and DPI Drug Products (Issued 9/19/1994, Posted 3/2/1998)

Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice)

Clinical Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal Register notice.)

Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children)

Clinical Evaluation of Antianxiety Drugs (Issued 9/77, Posted 3/2/1998)

Clinical Evaluation of Antidepressant Drugs (Issued 9/77, Posted 3/2/1998)

Clinical Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal Register notice.)

Clinical Evaluation of Antiepileptic Drugs (adults and children) (Issued 1/1981, Posted 3/2/1998)

Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per July 20, 2004, Federal Register notice.)

Clinical Evaluation of General Anesthetics (Issued 5/1982, Posted 3/2/1998)

Clinical Evaluation of Hypnotic Drugs (Issued 9/77, Posted 3/2/1998)

Clinical Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal Register notice.)

Clinical Evaluation of Local Anesthetics (Posted 3/2/1998)

Clinical Evaluation of Psychoactive Drugs in Infants and Children (Posted 3/2/1998)

Clinical Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal Register notice.)

Collection of Race and Ethnicity Data in Clinical Trials (Issued 9/16/2005, Posted 9/16/2005)

Content and Format for Pediatric Use Supplements

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products

Developing Medical Imaging Drug and Biological Products

Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004)

Part 2: Clinical Indications (Issued 6/17/2004, Posted 6/17/2004)

Part 3: Design, Analysis, and Interpretation of Clinical Studies (Issued 6/17/2004, Posted 6/17/2004)

Development and Use of Risk Minimization Action Plans (Issued 3/24/2005, Posted 3/24/2005)

Establishing Pregnancy Exposure Registries (Issued 8/2002, Posted 9/20/2002)

Evaluating the Risks of Drug Exposure in Human Pregnancies (Issued 4/27/2005, Posted 4/27/2005)

FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (Issued 12/1998, Posted 2/2/1999, posted 9/14/1999)

FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (Posted 3/2/1998)

FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July 20, 2004, Federal Register notice.)

Format and Content of the Clinical and Statistical Sections of an Application (Issued 7/1988, Posted 5/21/1997)

Format and Content of the Summary for New Drug and Antibiotic Applications* (Issued 2/1987, Posted 3/2/1998)

Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Issued 2/1987, Posted 3/2/1998)

General Considerations for the Clinical Evaluation of Drugs

General Considerations for the Clinical Evaluation of Drugs in Infants and Children (Issued 9/77, Posted 3/2/1998)

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (Issued 3/24/2005, Posted 3/24/2005)

Guidance for the Development of Vaginal Contraceptive Drugs (NDA) (Posted 3/2/1998)

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug and Biological Product Studies (Issued 1/2006)

IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revised 1/15/2004, Posted 1/15/2004)

Internal Radioactive Contamination—Development of Decorporation Agents (Issued 3/1/2006, Posted 3/1/2006)

Integration of Dose-Counting Mechanisms into MDI Drug Products (Issued 3/2003, Posted 3/12/2003)

Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (Issued 2/2001, Posted 3/8/2001)

Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer (Posted 3/2/1998)

Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer (Posted 3/2/1998)

Premarketing Risk Assessment (Issued 3/24/2005; Posted 3/24/2005)

Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Issued 8/27/1997, Posted 8/27/1997)

Postmarketing Reporting of Adverse Drug Experiences (Issued 3/1992, Posted 3/2/1998)

Preparation of Investigational New Drug Products (Human and Animal) (Issued 11/1992, Posted 3/2/1998)

Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Issued 5/14/1998, Posted 5/14/1998)

Prussian Blue Drug Products—Submitting a New Drug Application (Issued 1/2003, Posted 2/4/2003)

Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (Issued 7/22/1993, Posted 3/2/1998)

Study of Drugs Likely to be used in the Elderly (Issued 11/1989, Posted 3/2/1998)

Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1999, Posted 9/13/1999)

The Use of Clinical Holds Following Clinical Investigator Misconduct

Clinical/Medical (Draft)

Acne Vulgaris: Developing Drugs for Treatment (Issued 9/16/2005, Posted 9/16/2005)

Allergic Rhinitis: Clinical Development Programs for Drug Products (Issued 6/2000, Posted 6/20/2000)

Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment (Issued 6/2000, Posted 6/27/2000)

Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (Issued 7/07/1999, Posted 7/14/1999)

Clinical Evaluation of Lipid-Altering Agents (Issued 10/1990, Posted 2/18/1998)

Clinical Evaluation of Weight-Control Drugs (9/24/1996, Posted 2/18/1998)

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Issued 4/1/2005, Posted 4/1/2005)

Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (Issued 5/2000, Posted 6/13/2000)

Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Issued 9/6/2002)

Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Recommendations for Clinical Evaluation (Issued 1/2003, Posted 1/30/2003)

Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children (Posted 11/6/2001)

Exercise-Induced Bronchospasm (EIB)—Development of Drugs to Prevent EIB (Issued 2/2002, Posted 2/19/2002)

Exocrine Pancreatic Insufficiency Drug Products—Submitting NDAs (Posted 4/27/2004)

Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment (Issued 5/2000, Posted 5/18/2000)

Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Issued June 24, 2005, Posted June 27, 2005)

Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees (Issued 12/01/2005, Posted 2/07/2006)

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (3/31/2000)

Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (Issued 7/2002, Posted 7/25/2002)

OTC Treatment of Herpes Labialis with Antiviral Agents (Issued 3/8/2000, Posted 3/8/2000)

Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (Issued 2/2/2006), Posted 2/2/2006)

Pediatric Oncology Studies In Response to a Written Request (Issued 6/2000, Posted 6/19/2000)

Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis (Issued 4/1994, Posted 2/18/1998)

Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (Posted 12/1/2000)

Systemic Lupus Erythematosus—Developing Drugs for Treatment (Issued 3/28/2005, Posted 3/28/2005)

Clinical Pharmacology

Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (Issued 4/1997, Posted 4/8/1997)

Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications (Posted 5/5/2003)

Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application* (Issued 2/1987, Posted 3/2/1998)

In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling (Issued 11/24/1999, Posted 11/24/1999)

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (Posted 5/30/2003)

Pharmacokinetics in Patients with Impaired Renal Function (Issued 5/14/1998, Posted 5/14/1998)

Population Pharmacokinetics (Issued 2/1999, Posted 2/10/1999)

Clinical Pharmacology (Draft)

Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling (Issued 2/7/05, Posted 2/8/05)

General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (Issued 11/1998, Posted 11/12/1998)

Pharmacokinetics in Pregnancy—Study Design, Data Analysis, and Impact on Dosing and Labeling (Issued 10/29/2004, Posted 10/29/2004)

Combination Products (Drug/Device/Biologic)

Draft and Final guidances can be found on the Office of Combination Products web site.

Compliance

A Review of FDA's Implementation of the Drug Export Amendments of 1986 (Issued 11/1989, Posted 3/2/1998)

Compressed Medical Gases (Issued 2/1989, Posted 3/10/1997)

Computerized Systems Used in Clinical Trials (Issued 4/1999, Posted 5/11/1999)

General Principles of Process Validation

Good Laboratory Practice Regulations Questions and Answers (Posted 3/2/1998)

Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities—FDA Public Health Advisory (Issued and Posted 4/5/2001)

Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices (Posted 3/2/1998)

Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (Issued 6/27/1997, Posted 6/27/1997)

Monitoring of Clinical Investigations (Posted 3/2/1998)

Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Posted 3/2/1998)

Pharmacy Compounding—Compliance Policy Guide (Issued 5/2002, Posted 3/12/2004)

Possible Dioxin/PCB Contamination of Drug and Biological Products (Issued 8/23/1999, Posted 8/23/1999)

Prescription Drug Marketing Act—Donation of Prescription Drug Samples to Free Clinics (Issued 3/2006, Posted 3/13/2006)

Street Drug Alternatives (Issued 3/2000, Posted 3/31/2000)

Compliance (Draft)

Bar Code Label Requirements—Questions and Answers. (Issued 6/7/2005, Posted 6/7/2005)

Computerized Systems Used in Clinical Trials (Posted 9/29/2004)

Current Good Manufacturing Practice for Medical Gases (Posted 5/6/2003)

Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (5/27/2005)

Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24) Draft released for comment 3/30/2000 (5/12/2000)

Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (Issued 9/30/1998, Posted 9/30/1998)

Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (Issued 4/17/1998, Posted 4/17/1998)

Marketed Unapproved Drugs—Compliance Policy Guide (Issued 10/15/2003, Posted 10/17/2003)

PET Drug Products—Current Good Manufacturing Practice (CGMP) (Issued 9/15/2005, Posted 9/15/2005)

Drug Safety

Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Issued 2/2005, Posted 2/2005)

Drug Safety Draft

FDA's “Drug Watch” for Emerging Drug Safety Information (Issued 5/5/2005; Posted 5/5/2005)

Questions and Answers (Qs & As)

Electronic Submissions

Part 11, Electronic Records; Electronic Signatures—Scope and Application (Posted 9/3/2003)

Providing Regulatory Submissions in Electronic Format—ANDAs (Issued 6/2002, Posted 6/27/2002)

Providing Regulatory Submissions in Electronic Format—Content of Labeling (Issued 4/20/2005, Posted 4/20/2005)

Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. To ensure you have the most recent versions of the specifications referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is

http://www.fda.gov/cber/esub/esub.htm

. For CDER, this Web site is

http://www.fda.gov/cder/regulatory/ersr/ectd.htm

. (Issued 10/18/2005, Posted 10/18/2005)

Regulatory Submissions in Electronic Format; General Considerations (Issued 1/1999, Posted 1/27/1999)

Regulatory Submissions in Electronic Format; New Drug Applications (Issued 1/1999, Posted 1/27/1999)

SPL Standard for Content of Labeling Technical Qs & As ( Issued 12/2005, Posted 12/8/2005)

Example of an Electronic New Drug Application Submission (Posted 2/17/1999).

Electronic Submissions Draft

Providing Regulatory Submissions in Electronic Format—Annual Reports for NDAs and ANDAs (Posted 8/27/2003)

Providing Regulatory Submissions in Electronic Format—General Considerations (Issued 10/2003, Posted 10/22/2003)

Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports (Issued 5/2001, Posted 5/3/2001)

Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports (Posted 6/23/3003)

Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling (Issued 1/2001, Posted 1/30/2001)

Generics

180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (Issued 7/2003, Posted 7/31/2003)

Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Posted 12/12/2000)

ANDA's: Impurities in Drug Substances (Issued 11/1999, Posted 12/2/1999)

Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Posted 3/27/2000)

Handling and Retention of BA and BE Testing Samples (5/25/2004)

Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past. (Posted 3/2/1998)

Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process (Posted 3/2/1998)

Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (Posted 3/2/1998)

Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (Posted 3/2/1998)

Letter on the provision of new procedures and policies affecting the generic drug review process (Posted 3/2/1998)

Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (Posted 3/2/1998)

Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (Posted 3/2/1998)

Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (Posted 3/2/1998)

Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (Posted 3/2/1998)

Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (Issued 12/2001, Posted 12/20/2001)

Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 10/25/2005; Posted 10/25/2005)

Revising ANDA Labeling Following Revision of the RLD Labeling (Issued 4/26/2000, 4/26/2000)

Variations in Drug Products that May Be Included in a Single ANDA (Issued 12/1998, Posted 1/26/1999)

Generics (Draft)

ANDAs: Impurities in Drug Products (Issued 8/26/2005, Posted 8/26/2005)

ANDAs: Impurities in Drug Substances (Issued 1/28/2005, Posted 1/28/2005)

ANDAs: Pharmaceutical Solid Polymorphism (Issued 12/17/2004, Posted 12/17/2004)

Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—Questions and Answers (Issued 10/2004, Posted 11/3/2004)

Good Review Practices (GRPs)

Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Posted 2/18/2005)

Pharmacology/Toxicology Review Format (Posted 5/9/2001)

Good Review Practices (GRPs) (Draft)

Industry Letters

Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program (Posted 3/2/1998)

Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required (Posted 3/2/1998)

Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I (Posted 3/2/1998)

Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance (Posted 3/2/1998)

Implementation Plan USP injection nomenclature (Posted 3/2/1998)

Seventh of a series of letters about the Act providing guidance on the “130-day exclusivity” provision of section 505(j)(4)(B)(iv) of the FD&C (Posted 3/2/1998)

Sixth of a series of informal notice letters about the Act discussing 3- and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act (Posted 3/2/1998)

Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) (Posted 3/2/1998)

Third of a series of letters regarding the implementation of the Act (Posted 3/2/1998)

Year 2000 Letter from Dr. Janet Woodcock (10/19/98)

International Conference on Harmonisation

Safety

S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals

S1B Testing for Carcinogenicity of Pharmaceuticals (Issued 2/28/1998, Posted 3/24/1998)

S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals

S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes (Issued 12/4/1997, Posted 12/11/1997)

S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals

S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (Issued 11/21/1997, Posted 5/4/1998)

S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) Posted 6/25/99

S5A Detection of Toxicity to Reproduction for Medicinal Products (Issued 9/1994, Posted 4/23/1997)

S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility

S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (Issued 11/1997, Posted 11/18/1997)

S7A Safety Pharmacology Studies for Human Pharmaceuticals (Issued 7/2001, Posted 7/12/2001)

S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (Issued 10/19/2005, Posted 10/19/2005).

Joint Safety/Efficacy (Multidisciplinary)

M2 eCTD: Electronic Common Technical Document Specification (Posted 4/1/2003)

M2: eCTD Specification Questions and Answers and Change Requests (Posted 3/14/05)

Companion Document: Current Q & As and Change Requests (Issued 1/6/2006; Posted 1/6/2006)

M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (Issued 11/1997, Posted 11/25/1997)

M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (Posted 10/15/2001)

M4: Organization of the CTD

M4 Granularity Annex (Issued 10/18/2005, Posted 10/18/2005)

M4: The CTD—General Questions and Answers (Issued 12/04, Posted 12/22/2004)

M4: The CTD—Quality

M4: The CTD—Quality Questions and Answers /Location Issues (Issued 6/2004, Posted 6/8/2004)

M4: The CTD—Efficacy

M4: The CTD—Efficacy Questions and Answers (Issued 12/2004, Posted 12/22/2004)

M4: The CTD—Safety

M4: The CTD—Safety Appendices

M4: The CTD—Safety Questions and Answers (Issued 2/2003, Posted 2/4/2003)

Efficacy

E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports (Issued 1/15/1998, Posted 1/15/1998)

E2BM Data Elements for Transmission Of Individual Case Safety Reports (Issued 4/2002, Posted 4/4/2002)

E2B(M) Questions and Answers (Revised 3/09/2005, Posted, 3/16/2005)

E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (Issued 5/19/1997, Posted 3/19/1998)

E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (Posted 2/5/2004)

E2E Pharmacovigilance Planning (Issued 3/31/05; Posted 3/31/05)

E3 Structure and Content of Clinical Study Reports

E4 Dose-Response Information to Support Drug Registration

E5 Ethnic Factors in the Acceptability of Foreign Clinical Data

E5 Questions and Answers (Issue 6/2004, Posted 6/4/2004)

E6 Good Clinical Practice: Consolidated Guideline Spanish Version (Issued 5/9/1997, Posted 3/19/1998)

E7 Studies in Support of Special Populations: Geriatrics

E8 General Considerations for Clinical Trials (Issued 12/1997, Posted 12/17/1997)

E9 Statistical Principles for Clinical Trials (9/1/1998)

E10 Choice of Control Group and Related Issues in Clinical Trials (Issued 5/2001, Posted 5/11/2001)

E11 Clinical Investigation of Medicinal Products in the Pediatric Population (Issued 12/2000, Posted 12/14/2000)

E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (Issued 10/19/2005, Posted 10/19/2005)

Quality

Q1A(R2) Stability Testing of New Drug Substances and Products (Issued 11/2003, Posted 11/20/2003)

Q1B Photostability Testing of New Drug Substances and Products (Issued 11/1996, Reposted 7/7/1998)

Q1C Stability Testing for New Dosage Forms (Issued 5/9/1997, Posted 3/19/1998)

Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (Issued 1/2003, Posted 1/15/2003)

Q1E Evaluation of Stability Data (Issued 6/2004, Posted 6/7/2004)

Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV, revision 1 (7/1/2004)

Q2A Text on Validation of Analytical Procedures

Q2B Validation of Analytical Procedures: Methodology (Issued 5/19/1997, Posted 3/19/1997)

Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted 2/10/2003)

Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003)

Q3C Impurities: Residual Solvents or Adobe Acrobat version (Issued 12/24/1997, Posted 12/30/1997)

Q3C Tables and List (Posted 11/12/2003)

Appendix 4, Appendix 5, and Appendix 6 (Appendices were issued with the Q3C draft guidance documents)

Maintenance Procedures for Updating (Posted 2/11/2002)

Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (Posted 9/1998)

Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Issued 9/21/1998, Posted 9/21/1998)

Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (Issued 6/2005, Posted 6/29/2005)

Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. (12/29/2000)

Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Issued 8/1999, Posted 12/14/2001)

Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Issued 8/2001, Posted 9/24/2001]

International Conference on Harmonisation (Draft)

Efficacy

E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (Issued 9/30/2005, Posted 9/30/2005)

E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (Posted 9/12/2003)

Principles for Clinical Evaluation of New Antihypertensive Drugs. (Issued 8/2000, Posted 8/8/2000)

Joint Safety/Efficacy (Multidisciplinary) (Draft)

International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries (Issued 9/2005, Posted 9/2/2005)

Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001)

Quality

Q8 Pharmaceutical Development (Issued 2/7/2005, Posted 2/8/2005)

Q9 Quality Risk Management (Issued 8/5/2005, Posted 8/5/2005)

Safety

S8 Immunotoxicity Studies for Human Pharmaceuticals (Issued 2/7/05, Posted 2/8/05)

Investigational New Drug Applications

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs

Labeling

Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (Issued 1/18/2006; Posted 1/18/2006)

Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (Issued 1/18/2006; Posted 1/18/2006)

Content and Format for Geriatric Labeling (Issued 10/2001, Posted 10/4/2001)

Labeling (Draft)

Labeling for Combined Oral Contraceptives (Issued 3/2/2004, Posted 3/4/2004)

Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements (Issued 1/18/2006; Posted 1/18/2006)

Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) (Issued 6/1998, Posted 7/20/1998)

Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Recommended Prescribing Informtion for Health Care Providers and Patient Labeling (Issued 11/15/2005, Posted 11/15/2005)

Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (Issued 10/2000, Posted 10/25/2000)

Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format (Issued 1/18/2006; Posted 1/18/2006)

Microbiology

Format and Content of the Microbiology Section of an Application*

Modernization Act of 1997

Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004)

Classifying Resubmissions in Response to Action Letters (Issued 5/14/1998, Posted 5/14/1998)

Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/1998, Posted 11/20/1998)

Fast Track Drug Development Programs—Designation, Development, and Application Review (Posted 7/22/2004)

Appendix 2; Appendix 3 consisting of Mapp 6020.3 and SOPP 8405; and Appendix 4 [Appendices are scanned copies, which will be replaced by final versions] (Issued 11/17/1998, Posted 11/17/1998)

Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000)

Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000)

Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997—Advisory Committees (Issued 10/1998, Posted 11/02/98)

Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements (Issued 7/1998, Posted 7/20/98)

Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002, Posted 3/18/2002)

National Uniformity for Nonpresciption Drugs—Ingredient Listing for OTC Drugs (Issued 4/1998, Posted 5/5/1998)

Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Issued 5/14/1998, Posted 5/14/1998)

Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/1999, Posted 10/4/1999)

Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric “Rule,” and Their Interaction (Posted 7/27/1999)

Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (Revised 5/1998, Posted 6/12/1998)

Standards for Prompt Review of Efficacy Supplements (Issued 5/15/1998, Posted 5/15/1998)

Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1998, Posted 9/15/98)

Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000

Women and Minorities Guidance Requirements (Issued 7/20/1998, Posted 11/25/1998)

Modernization Act of 1997 (Draft)

Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004, Posted 1/27/2004)

PET Drug Applications—Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000)

Sample formats for chemistry, manufacturing, and controls sections

Sample formats for labeling

Sample formats for Form FDA 356h

Sample formats for user fee Form FDA 3397

Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (Posted 4/4/2001)

Over-the-Counter (OTC) Guidances

Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) (Posted 3/2/1998)

General Guidelines for OTC Combination Products (Posted 3/2/1998)

Labeling OTC Human Drug Products Using a Column Format (Issued 12/2000, Posted 12/18/2000)

Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs

Example Drug Facts Labels

Acetaminophen 120 mg in a Suppository Dosage Form

Acetaminophen 325 mg in a Suppository Dosage Form

Acetaminophen 650 mg in a Suppository Dosage Form

Cimetidine 200 mg in a Tablet Dosage Form

Clemastine Fumerate 1.34 mg in a Tablet Dosage Form

Doxylamine Succinate 25 mg Tablet Dosage Form

Ibuprofen 200 mg in a Tablet/Capsule Dosage Form

Loperamide HCl in a Liquid Dosage Form

Loperamide HCl in a Tablet/Caplet Dosage Form

Miconazole Nitrate Vaginal Products

Minoxidil Topical Solution 2% for Men and Women

Minoxidil Topical Solution 5% for Men

Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form

Pseudoephedrine HCl Extended-Release Tablets 120 mg

Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) (Posted 3/2/1998)

Over-the-Counter (OTC) Draft

Labeling OTC Human Drug Products Questions and Answers (Issued 1/2005, Posted 1/12/05

Labeling OTC Human Drug Products—Submitting Requests for Exemptions and Deferrals (Issued 12/2000, Posted 12/18/2000)

Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005)

Labeling OTC Human Drug Products Updating Labeling in ANDAs (2/21/2001)

Additional examples 1 (3/19/2001)

Additional examples 2 (3/26/2001)

Additional examples 3 (3/26/2001)

Time and Extent Applications (Issued 2/2004, Posted 2/11/2004)

Pharmacology/Toxicology

Carcinogenicity Study Protocol Submissions (Issued 5/22/2002)

Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products

Developing Medical Imaging Drug and Biological Products

Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004)

Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (Issued 7/21/2005, Posted 7/21/2005.

Exploratory IND Studies (Issued 1/12/2006; Posted 1/12/2006)

Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (Posted 3/2/1998)

Immunotoxicology Evaluation of Investigational New Drugs (Issued 10/2002, Posted 10/31/2002)

Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives

Nonclinical Safety Evaluation of Pediatric Drug Products (Issued 2/14/2006, Posted 2/14/2006)

Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Issued 05/18/2005, Posted 05/18/2005)

Photosafety Testing (Posted 5/7/2003)

Recommended Approaches to Integration of Genetic Toxicology Study Results (Issued 1/3/2006, Posted 1/3/2006).

Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (Posted 3/2/1998)

Single Dose Acute Toxicity Testing for Pharmaceuticals

Pharmacology/Toxicology Draft

Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (Issued 11/2001, Posted 11/9/2001)

Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (Issued 6/17/2005; Posted 6/17/2005)

Nonclinical Safety Evaluation of Drug Combinations (Issued 1/26/05, Posted 1/26/05)

Safety Testing of Drug Metabolites (Issued 6/2005, Posted 6/3/2005)

Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (Issued 5/2001, Posted 5/7/2001)

Procedural

180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Issued 6/1998, Posted 6/22/1998)

Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under PDUFA (Posted 10/1/2003)

Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA (Posted 10/1/2003)

Paperwork Reduction Act Burden Statement (Posted 7/27/2004)

Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Posted 3/27/2000)

Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 (Issued 11/1999, Posted 11/29/1999)

Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate—Labeling Enforcement Policy (Posted 6/3/2003)

Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/1998, Posted 11/20/1998)

Fast Track Drug Development Programs—Designation, Development, and Application Review (Posted 1/12/2006)

Appendix 2 ; Appendix 3 consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 [Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998)

FDA Export Certicates (Issued 7/2004, Posted 7/13/2004)

Financial Disclosure by Clinical Investigators (3/27/2001)

Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000)

Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000)

Good Review Management Principles and Practices for PDUFA Products (Issued 3/2005; Posted 3/30/2005)

Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations (Revised 6/2003)

Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997—Advisory Committees (Issued 10/1998, Posted 11/02/98)

Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements (Issued 7/1998, Posted 7/20/98)

Independent Consultants for Biotechnology Clinical Trial Protocols (Issued 8/18/2004, Posted 8/192/2004)

Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002, Posted 3/18/2002)

Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001)

Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (Issued 7/2001, Posted 7/12/2001)

National Uniformity for Nonpresciption Drugs—Ingredient Listing for OTC Drugs (Issued 4/1998, Posted 5/5/1998)

Pharmacogenomic Data Submissions (Issued 3/2005, Posted 3/22/2005)

Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Issued 3/2005, Posted 3/22/2005)

Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (Issued 12/2001, Posted 12/10/2001)

KI in Radiation Emergencies—Questions and Answers (Issued 12/20/2002, Posted 12/23/2002)

Potassium Iodide Tablets—Shelf Life Extension (Posted 3/8/2004)

Reduction of Civil Money Penalties for Small Entities (Issued 3/20/2001)

Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/1999, Posted 10/4/1999)

Refusal to File (Issued 7/12/1993, Posted 11/26/99)

Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (Revised 5/1998, Posted 6/12/1998)

Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (Issued 2/15/2006; Posted 2/15/2006)

Special Protocol Assessment (Issued 5/2002, Posted 5/16/2002)

Standards for Prompt Review of Efficacy Supplements (Issued 5/15/1998, Posted 5/15/1998)

Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000)

Procedural Draft

Applications Covered by Section 505(b)(2) (Issued 10/1999, Posted 12/7/1999)

Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research, Beginning on January 1, 2000 (Issued 12/1999, Posted 12/22/1999)

Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees (2/14/2002)

Emergency Use Authorization of Medical Products; Availability (Issued 7/5/2005; Posted 7/5/2005.

Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV (5/17/2004)

Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (5/14/2001)

How to Comply with the Pediatric Research Equity Act (Posted 9/7/2005)

Independent Consultants for Biotechnology Clinical Trial Protocols (Posted 5/7/2003)

Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004, Posted 1/27/2004)

PET Drug Applications—Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000)

Sample formats for chemistry, manufacturing, and controls sections

Sample formats for labeling

Sample formats for Form FDA 356h

Sample formats for user fee Form FDA 3397

Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (Issued 3/2001, Posted 3/9/2001)

Submitting Debarment Certification Statements (Issued 10/2/98, Posted 10/2/98)

Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001)

The Use of Clinical Holds Following Clinical Investigator Misconduct (Issued 4/2002, Posted 8/26/2002)

Useful Written Consumer Medication Information (CMI) (Issued 5/25/2005, Posted 5/25/2005)

Using a Centralized IRB Review Process in Multicenter Clinical Trials (Issued 3/25/2005, Posted 3/25/2005)

Small Entity Compliance Guides

Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation—Small Entity Compliance Guide (Posted 11/7/2001)

Small Entity Compliance Guides (Draft)

Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005)

User Fees

Classifying Resubmissions in Response to Action Letters (Issued 5/14/1998, Posted 5/14/1998)

Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (Issued 6/1999, Posted 6/25/99)

Guidance for Industry and FDA Staff: Application User Fees for Combination Products. (Issued 4/2005, Posted 5/3/2005)

Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001)

Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (Issued 12/30/2004, Posted 12/30/2004)

User Fees (Draft)

Attachment G—Draft Interim Guidance Document for Waivers of and Reductions in User Fees (7/16/1993)

User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (Issued 4/15/2005, Posted 4/15/2005)

Also see Current Good Manufacturing Practice Regulations

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations (Posted 8/11/1997)

IV. Center for Devices and Radiological Health (CDRH)

For information on a specific guidance document or to obtain a hard copy, contact: Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 1-800-638-2041 or 301-443-6597,

http://www.fda.gov/cdrh/guidance.html

.

The following is a list of CDRH guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

Title of Document

Date of Issuance

Date of Withdrawal

Methods for Conducting Recall Effectiveness Checks

June 16, 1978

January 2006

Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA

March 1, 2001

September 7, 2005

Guidance for Industry; In Vitro Diagnostic C-Reactive Protein Immunological Test System

July 20, 1998

September 22, 2005

Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)s

July 22, 2000

September 7, 2005

Draft Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms

June 14, 1993

December 8, 2005

CDRH Interim Regulatory Policy for External Penile Rigidity Devices

September 10, 1997

January 2005

Guidance for Neurological Embolization Devices

November 1, 2000

January 2005

Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices

Draft of this document was issued on June 30, 2004

Final issued on: April 28, 2005

Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices

Draft of this document was issued on February 25, 2004

Final issued on: December 29, 2004

Class II Special Controls Guidance Document: External Penile Rigidity Devices

Draft of this document was issued March 17, 2004

Final issued on: December 28, 2004

The following is a copy of a list of current CDRH guidance documents obtained from the FDA Web site as of March14, 2006.

CDRH Guidance Documents (obtained from the FDA Web site on March 14, 2006)

(1) A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems 979 03/01/1996

(2) Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic Products 951 08/01/1995

(3) Compliance Program for Field Compliance Testing of Cabinet X-Ray Equipment (CP 7386.004); Final Guidance for Industry and FDA Staff 57 02/26/2001

(4) Compliance Program Guidance Manual: Field Implementation of the Sunlamp and Sunlamp Product Performance Standard, as amended; Final Guidance for Industry and FDA 75 10/06/2001

(5) Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter—Guidance for Industry and FDA Staff 1544 11/08/2004

(6) Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 241 02/01/1975

(7) Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products; Guidance for Industry and FDA 1412 07/12/2002

(8) Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use 399 09/01/1996

(9) Guide for Preparing Annual Reports for Ultrasonic Therapy Products 261 09/01/1996

(10) Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) 243 10/01/1987

(11) Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps 263 09/01/1995

(12) Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products 262 09/01/1995

(13) Guide for Preparing Product Reports for Medical Ultrasound Products 960 09/01/1996

(14) Guide for Preparing Product Reports for Ultrasonic Therapy Products (physical therapy only) 249 08/01/1996

(15) Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21-CFR 1002) 279 09/01/1995

(16) Guide for Preparing Reports on Radiation Safety of Microwave Ovens 239 03/01/1985

(17) Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21-CFR 1002.10 235 04/01/1971

(18) Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21-CFR 1002.10 240 04/30/1974

(19) Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137) 254 09/01/1980

(20) Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21-CFR 1002.10 237 03/01/1973

(21) Information Requirements for Cookbooks and User and Service Manuals 697 10/31/1988

(22) Keeping Up With the Microwave Revolution (FDA Pub No. 91-4160) 356 03/01/1990

(23) Laser Light Show Safety—Who's Responsibility (FDA 86-8262) 13 05/01/1986

(24) Laser Products—Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance for Industry and FDA (Laser Notice 50) 1346 07/26/2001

(25) Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards Exist 231 05/28/1981

(26) Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products 342 08/21/1986

(27) Quality Control Guide for Sunlamp Products (FDA 88-8234) 270 03/01/1988

(28) Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard 349 05/01/1980

(29) Reporting and Compliance Guide for Television Products including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance 260 10/01/1995

(30) Reporting Guide for Laser Light Shows and Displays (21-CFR1002) (FDA 88-8140) 251 09/01/1995

(31) Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002) 348 09/01/1995

(32) Reporting of New Model Numbers to Existing Model Families 675 06/14/1983

(33) Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127) 264 09/01/1995

(34) Suggested State Regulations for Control of Radiation—Volume II Nonionizing Radiation—Lasers (FDA Pub No. 83-8220) 70 01/01/1982

(35) Wireless Medical Telemetry Risks and Recommendations 1173 09/27/2000

(36) Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA CBER 1201 02/25/2003

(37) Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002—Identification of Manufacturer of Medical Devices—Draft Guidance for Industry and FDA Staff CBER 1217 06/23/2003

(38) Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals CBER 09/06/2002

(39) Guidance for Industry: FDA Export Certificates CBER 1417 07/12/2004

(40) “Help-Seeking” and Other Disease Awareness Communications by or on behalf of Drug and Device Firms - Draft Guidance for Industry CBER CDER CDRH 02/10/2004

(41) Bundling Multiple Devices or Multiple Indications in a Single Submission—Guidance for Industry and FDA Staff CBER CDRH 1215 11/26/2003

(42) Expedited Review of Premarket Submissions for Devices—Guidance for Industry and FDA Staff CBER CDRH 108 11/26/2003

(43) FY 2005 MDUFMA Small Business Qualification Worksheet and Certification—Guidance for Industry and FDA CBER CDRH 2005 08/02/2004

(44) FY 2006 MDUFMA Small Business Qualification Worksheet and Certification—Guidance for Industry and FDA CBER CDRH 2006 08/17/2005

(45) Guidance for Industry and FDA Staff—Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use CBER CDRH 4444 11/30/2004

(46) Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002—Gudiance for Industry, FDA Staff, and FDA-Accredited Third-Parties CBER CDRH 1532 09/15/2005

(47) Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA—Guidance for Industry and FDA Staff CBER CDRH 1303 11/17/2004

(48) User Fees and Refunds for Premarket Approval Applications—Guidance for Industry and FDA Staff CBER CDRH 1224 11/24/2003

(49) User Fees and Refunds for Premarket Notification Submissions (510(k)s)—Guidance for Industry and FDA Staff CBER CDRH 1511 05/28/2004

(50) Acceptance of Foreign Clinical Studies; Guidance for Industry CDER 03/13/2001

(51) Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis CDER 2199 07/07/1999

(52) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—General Considerations CDER 10/22/2003

(53) Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds Developing Products for Treatment CDER 06/01/2000

(54) Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials CDER 09/01/2005

(55) Part 11, Electronic Records; Electronic Signatures—Scope and Application CDER 09/05/2003

(56) Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties CDRH 1200 10/04/2004

(57) Alternative to Certain Prescription Device Labeling Requirements OC 1150 01/21/2000

(58) Civil Money Penalty Policy OC 1124 06/08/1999

(59) Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub No. 95-4246) OC 10 03/01/1995

(60) Color Additive Petitions (p. II-19 of PMA Manual) OC 296 06/01/1987

(61) Color Additive Status List (Inspection Operations Manual) OC 268 02/01/1989

(62) Commercial Distribution/Exhibit Letter OC 246 04/10/1992

(63) Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended—Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices—Draft Guidance for Industry and FDA Staff OC 1217 10/11/2005

(64) Consumer-Directed Broadcast Advertising of Restricted Devices OC 1513 02/10/2004

(65) FDA Guide for Validation of Biological Indicator Incubation Time OC 283 01/01/1986

(66) General Principles of Software Validation; Final Guidance for Industry and FDA Staff OC 938 01/11/2002

(67) Guidance on Performance Standard for Lead Wires and Patient Cables OC 1197 03/09/1998

(68) Guideline for the Monitoring of Clinical Investigations OC 428 01/01/1988

(69) Implementation of the Biomaterials Access Assurance Act of 1998; Draft Guidance for Industry and FDA OC 1324 04/02/2001

(70) Letter to Medical Device Manufacturer on Pentium processors OC 456 02/14/1995

(71) Medical Device Tracking—Guidance for Industry and FDA Staff OC 169 05/05/2003

(72) Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) OC 295 09/01/1989

(73) Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [Section 510(k)] [CPG 7124.19] OC 181 09/24/1987

(74) Sterilized Convenience Kits for Clinical and Surgical Use; Final Guidance for Industry OC 1390 01/07/2002

(75) User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry OC 1212 04/01/2003

(76) Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects OC/DBM 2229 03/19/1999

(77) Regulating In Vitro Diagnostic Device (IVD) Studies OC/DBM 1132 12/17/1999

(78) Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables OC/DE1 1129 11/15/1999

(79) Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi) OC/DE1 545 05/17/1993

(80) All U.S. Condom Manufacturers, Importers and Repackagers OC/DE2 2510 04/07/1987

(81) Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/8/87) OC/DE2 293 04/08/1987

(82) Dental Handpiece Sterilization (Dear Doctor Letter) OC/DE2 589 09/28/1992

(83) Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms OC/DE2 1139 08/14/2000

(84) Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure OC/DE2 1019 06/23/1978

(85) Hazards of Volume Ventilators and Heated Humidifiers OC/DE2 901 09/15/1993

(86) Latex Labeling Letter (Johnson) OC/DE2 831 03/18/1993

(87) Letter—Condom Manufacturers and Distributors OC/DE2 56 04/05/1994

(88) Letter—Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) OC/DE2 52 02/23/1994

(89) Letter—Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) OC/DE2 53 02/13/1989

(90) Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson OC/DE2 869 05/10/1993

(91) Letter to Manufacturers/Repackers Using Cotton OC/DE2 101 04/22/1994

(92) Letter to Ophthalmologists about Lasers for Refractive Surgery OC/DE2 8323 06/27/1997

(93) Manufacturers and Initial Distributors of Hemodialyzers OC/DE2 2507 05/23/1996

(94) Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals OC/DE2 933 02/03/1994

(95) Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims OC/DE2 851 06/30/1994

(96) Prospective Manufacturers of Barrier Devices used during Oral Sex for STD Protection OC/DE2 1394 10/31/1996

(97) Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy OC/DE2 1122 08/23/1996

(98) Standard Specification for Rubber Contraceptives (Condoms) OC/DE2 628 10/28/1983

(99) Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Guidance for Industry—Draft OC/DE2 1141 07/26/2000

(100) Labeling for Male Condoms Made of Natural Rubber Latex—Class II Special Controls Guidance Document—Draft Guidance for Industry and FDA Staff OC/DE2/OBGUB 1548 11/14/2005

(101) Computerized Devices/Processes Guidance—Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes OC/DE3 247 05/01/1992

(102) Design Control Guidance for Medical Device Manufacturers OC/DE3 994 03/11/1997

(103) Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals OC/DE3 1168 08/14/2000

(104) Guidance for Industry: Labeling for Electronic Anti-Theft Systems OC/DE3 1170 08/15/2000

(105) Keeping Medical Devices Safe from Electromagnetic Interference OC/DE3 1081 07/01/1995

(106) Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA OC/DE3 1392 07/30/2001

(107) Letter to Trade Association: ReUse of Single-use or Disposable Medical Devices OC/DE3 961 12/27/1995

(108) Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations OC/DE3 1086

(109) Medical Devices and EMI: The FDA Perspective OC/DE3 1082 01/01/1995

(110) Quality Assurance Guidelines for Hemodialysis Devices OC/DE3 507 02/01/1991

(111) Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff OC/DE3 1140 02/03/2003

(112) Safety of Electrically Powered Products: Letter To Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memo# OC/DE3 1087 09/18/1996

(113) Unsafe Patient Lead Wires and Cables OC/DE3 889 09/03/1993

(114) Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval OC/DPO 1269 08/05/1999

(115) Inspection of Medical Device Manufacturers; Final Guidance for Industry and FDA OC/DPO/FPB 1702 02/07/2001

(116) Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products OCD 01/28/1998

(117) FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment—Guidance for Industry and FDA Staff OCD 1218 10/08/2003

(118) FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment—Guidance for Industry and FDA Staff OCD 1219 05/21/2004

(119) Guidance for Industry: Financial Disclosure by Clinical Investigators OCD 03/20/2001

(120) Premarket Assessment of Pediatric Medical Devices—Guidance for Industry and FDA Staff OCD 1220 05/14/2004

(121) Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA OCD 1121 07/02/2001

(122) FDA Modernization Act of 1997: Guidance for the Device Industry on Implementation of Highest Priority Provisions; Availability OCER 434 02/06/1998

(123) CDRH Manual for Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff OCER/DDUPSA 1323 02/09/2001

(124) Do It By Design—An Introduction to Human Factors in Medical Devices OCER/DDUPSA 995 12/01/1996

(125) Frequently Asked Questions about the Reprocessing and Reuse of Single Use Devices by Third Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff OCER/DDUPSA 1333 07/06/2001

(126) Frequently Asked Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions—Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors OCER/DDUPSA 1427 07/16/2003

(127) Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Three Additional Questions; Final Guidance for Industry and FDA Staff OCER/DDUPSA 1408 07/09/2002

(128) Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers OCER/DDUPSA 1128 04/19/2001

(129) Human Factors Points to Consider for IDE Devices OCER/DDUPSA 839 01/17/1997

(130) Human Factors Principles for Medical Device Labeling OCER/DDUPSA 227 09/01/1993

(131) Medical Device Reporting for User Facilities OCER/DDUPSA 989 04/01/1996

(132) Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management OCER/DDUPSA 1497 07/18/2000

(133) Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies OCER/DMQRP 1071 08/13/1998

(134) Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) OCER/DMQRP 758 03/01/1989

(135) The Mammography Quality Standards Act Final Regulations Document 3 OCER/DMQRP 1496 07/18/2000

(136) The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #11—Guidance for Industry, MQSA Inspectors, and FDA Staff OCER/DMQRP 1569 08/12/2005

(137) The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #10—Guidance for Industry and FDA Staff OCER/DMQRP 1554 10/31/2005

(138) The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9—Draft Guidance for Industry and FDA OCER/DMQRP 1539 07/15/2005

(139) Guidance for Industry and FDA Staff—Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54) OCER/DMQRP OCER/DMQRP/EPDB 1592 01/06/2006

(140) A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use OCER/DMQRP/DDB 978 03/01/1996

(141) A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use OCER/DMQRP/DDB 977 03/01/1996

(142) A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components OCER/DMQRP/DDB 257 01/01/1982

(143) Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-ray Equipment OCER/DMQRP/DDB 1133 03/15/2000

(144) Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems OCER/DMQRP/DDB 271 12/01/1985

(145) Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff OCER/DMQRP/DDB 2619 09/05/2003

(146) Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) OCER/DMQRP/DDB 116 10/13/1993

(147) Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)—E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems OCER/DMQRP/EPDB 236 08/01/1995

(148) Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)—Guidance for Industry and FDA Staff OCER/DMQRP/EPDB 1565 11/06/2005

(149) Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device OCER/DMQRP/EPDB 903 03/01/1987

(150) Compliance Guide for Laser Products (FDA 86-8260) OCER/DMQRP/EPDB 278 09/01/1985

(151) Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers OCER/DMQRP/EPDB 343 09/16/1981

(152) Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] OCER/DMQRP/EPDB 286 03/01/1988

(153) Guide for Preparing Product Reports for Lasers and Products Containing Lasers OCER/DMQRP/EPDB 277 09/01/1995

(154) Guide for the filing of Annual Reports for X-Ray Components and Systems OCER/DMQRP/EPDB 253 07/01/1980

(155) Imports Radiation-Producing Electronic Products (FDA 89-8008) OCER/DMQRP/EPDB 756 11/01/1988

(156) Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 OCER/DMQRP/EPDB 880 08/24/1981

(157) Open Door Operation of Microwave Ovens as a Result of Oven Miswiring OCER/DMQRP/EPDB 646 03/28/1980

(158) Policy on Lamp Compatibility (sunlamps) OCER/DMQRP/EPDB 2343 09/02/1986

(159) Policy on Warning Label Required on Sunlamp Products OCER/DMQRP/EPDB 1343 06/25/1985

(160) Procedures for Laboratory Compliance Testing of Television Receivers OCER/DMQRP/EPDB 945 05/01/1986

(161) Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA—Laser Notice 51 OCER/DMQRP/EPDB 1349 05/27/2001

(162) Compliance Guidance—The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final Guidance for Industry and FDA OCER/DMQRP/ICB 6400 11/05/2001

(163) Guidance for Industry and FDA Staff—Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA OCER/DMQRP/ICB 6409 09/13/2005

(164) 510(k) Manual—Premarket Notification: 510(k)—Regulatory Requirements for Medical Devices OCER/DSMICA 469 08/01/1995

(165) Certification Statement for the Impact Resistance Test OCER/DSMICA 1460 10/25/1993

(166) Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 OCER/DSMICA 133

(167) DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Overview, Medical Device Annex, Version 7 June 29, 2000 OCER/DSMICA 1396

(168) DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Procedures, Medical Device Annex, Version 7 June 29, 2000 OCER/DSMICA 1397

(169) Draft Medical Glove Guidance Manual OCER/DSMICA 852 07/30/1999

(170) Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) OCER/DSMICA 1114 01/06/1999

(171) Impact Resistant Lenses: Questions and Answers (FDA 87-4002) OCER/DSMICA 23 09/01/1987

(172) Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties OCER/DSMICA 1160 02/02/2001

(173) In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions OCER/DSMICA 471 01/01/1997

(174) Labeling—Regulatory Requirements for Medical Devices (FDA 89-4203) OCER/DSMICA 470 09/01/1989

(175) Medical Device Appeals and Complaints: A Guidance on Dispute Resolution OCER/DSMICA 396 02/19/1998

(176) Medical Device Quality Systems Manual: A Small Entity Compliance Guide OCER/DSMICA 6303 12/01/1996

(177) Medical Device Reporting for Manufacturers OCER/DSMICA 987 03/01/1997

(178) Overview of FDA Modernization Act of 1997, Medical Device Provisions OCER/DSMICA 1174 02/19/1998

(179) Regulation of Medical Devices: Background Information for International Officials OCER/DSMICA 610 04/14/1999

(180) #D95-2, Attachment A (Interagency Agreement between FDA & HCFA) ODE 2106 09/15/1995

(181) #D95-2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA) ODE 3106 09/15/1995

(182) 30-Day Notices and 135-day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH (Docket 98D-0080); Final ODE 795 02/19/1998

(183) 510(k) Additional Information Procedures #K93-1 (blue book memo) ODE 886 07/23/1993

(184) 510(k) Quality Review Program (blue book memo) ODE 344 03/29/1996

(185) 510(k) Refuse to Accept Procedures #K94-1 (blue book memo) ODE 401 05/20/1994

(186) 510(k) Sign-Off Procedures #K94-2 (blue book memo) ODE 308 06/03/1994

(187) A New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications ODE 905 03/20/1998

(188) A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff ODE 1347 11/10/2005

(189) A Suggested Approach to Resolving Least Burdensome Issues ODE 1188 09/11/2000

(190) Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices ODE 267 12/01/1983

(191) Assignment of Review Documents #I90-2 (blue book memo) ODE 366 08/24/1990

(192) Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff ODE 1341 07/18/2001

(193) Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy ODE 4859 06/30/1993

(194) Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy—(updated Checklist 3/14/1995) ODE 3859 06/30/1993

(195) Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff ODE 1337 05/29/2001

(196) Classified Convenience Kits ODE 789 04/30/1993

(197) Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) ODE 30 10/19/1990

(198) Consolidated Review of Submissions for Lasers and Accessories #G90-1 (blue book memo) ODE 31 10/19/1990

(199) Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) ODE 872 07/15/1996

(200) Convenience Kits Interim Regulatory Guidance ODE 562 05/20/1997

(201) Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95-1) ODE 406 11/21/1995

(202) Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) ODE 935 01/10/1997

(203) Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry ODE 1073 11/30/2000

(204) Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff ODE 857 12/03/2002

(205) Device Labeling Guidance #G91-1 (blue book memo) ODE 414 03/08/1991

(206) Distribution and Public Availability of PMA Summary of Safety and Effectiveness Data Packages ODE 563 10/10/1997

(207) Document Review Processing #I91-1 (blue book memo) ODE 446 02/12/1992

(208) Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (blue book memo) ODE 920 12/23/1993

(209) Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff ODE 310 02/28/2001

(210) Format for IDE Progress Reports ODE 311 06/01/1996

(211) Frequently Asked Questions on the New 510(k) Paradigm; Final ODE 2230 10/22/1998

(212) Goals and Initiatives for the IDE Program #D95-1 (blue book memo) ODE 405 07/12/1995

(213) Guidance for Industry; General/Specific Intended Use; Final ODE 499 11/04/1998

(214) Guidance for Off-the-Shelf Software Use in Medical Devices; Final ODE 585 09/09/1999

(215) Guidance for Submitting Reclassification Petition ODE 609 01/01/1997

(216) Guidance on Amended Procedures for Advisory Panel Meetings; Final ODE 413 07/22/2000

(217) Guidance on IDE Policies and Procedures; Final ODE 882 01/20/1998

(218) Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—for Use by CDRH and Industry; Final ODE 322 02/19/1998

(219) Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 ODE 1135 08/09/2000

(220) Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (blue book memo) ODE 289 06/30/1986

(221) Guidance on the Use of Standards in Substantial Equivalence Determinations; Final ODE 1131 03/12/2000

(222) Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final ODE 380 05/20/1998

(223) Guideline on General Principles of Process Validation ODE 425 05/01/1987

(224) Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test ODE 427 12/01/1987

(225) HCFA Reimbursement Categorization Determinations for FDA-approved IDEs ODE 4106 09/15/1995

(226) Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry ODE 1381 07/12/2001

(227) IDE Refuse to Accept Procedures #D94-1 (blue book memo) ODE 410 05/20/1994

(228) Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) ODE 106 09/15/1995

(229) Indications for Use Statement ODE 879 01/02/1996

(230) Industry Representatives on Scientific Panel ODE 329 03/27/1987

(231) Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) ODE 447 05/29/1991

(232) Kit Certification for 510(k)s ODE 562 07/01/1997

(233) Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance ODE 198 04/01/1996

(234) Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D.,M.D. ODE 883 05/26/1994

(235) Limulus Amebocute Lysate; Reduction of Samples for Testing ODE 178 10/23/1987

(236) Master Files Part III; Guidance on Scientific and Technical Information ODE 338 06/01/1987

(237) Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final ODE 2206 11/16/1998

(238) Meetings with the Regulated Industry #I89-3 (blue book Memo) ODE 367 11/20/1989

(239) Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3) ODE 806 08/09/1996

(240) Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions ODE 639 06/13/1995

(241) Methods for Conducting Recall Effectiveness Checks ODE 225 06/16/1978

(242) New section 513(f)(2)—Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff; Final ODE 199 02/19/1998

(243) Nondisclosure of Financially Sensitive Information #I92-1 (blue book memo) ODE 587 03/05/1992

(244) ODE Executive Secretary Guidance Manual G87-3 ODE 1338 08/07/1987

(245) Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) ODE 306 04/18/1986

(246) Panel Review of Premarket Approval Applications #P91-2 (blue book memo) ODE 444 05/03/1991

(247) Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff ODE 1208 06/03/2003

(248) PMA Compliance Program #P91-3 (blue book memo) ODE 445 05/03/1991

(249) Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products ODE 269 06/01/1984

(250) Policy Development and Review Procedures #I90-1 (blue book memo) ODE 368 02/15/1990

(251) Preamendment Class III Devices ODE 584 03/11/1992

(252) Preamendments Class III Strategy ODE 611 04/19/1994

(253) Premarket Approval Application (PMA) Closure #P94-2 (blue book memo) ODE 403 07/08/1994

(254) Premarket Approval Application Modular Review—Guidance for Industry and FDA Staff ODE 835 11/03/2003

(255) Premarket Notification—Consistency of Reviews #K89-1 (blue Book memo) ODE 339 02/28/1989

(256) Premarket Notification [510(k)] Status Request Form ODE 858 03/07/1994

(257) Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff; Final ODE 159 02/19/1998

(258) Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities ODE 1198 09/03/1996

(259) Real-Time Review Program for Premarket Approval Application (PMA) Supplements ODE 673 04/22/1997

(260) Review of IDEs for Feasibility Studies #D89-1 (blue book memo) ODE 362 05/17/1989

(261) Review of Laser Submissions #G88-1 (blue book memo) ODE 330 04/15/1988

(262) Shelf Life of Medical Devices ODE 415 04/01/1991

(263) SMDA Changes—Premarket Notification; Regulatory Requirements for Medical Devices (510k) Manual Insert ODE 655 04/17/1992

(264) Substantial Equivalence (SE) Decision Making Documentation ATTACHED: 'SE' Decision Making Process (Detailed) i.e. the decision making tree ODE 390 01/01/1990

(265) Suggested Content for Original IDE Application Cover Letter ODE 797 02/27/1996

(266) Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA ODE 1195 11/02/2000

(267) Telephone Communications Between ODE Staff and Manufacturers #I93-1 (blue book memo) ODE 360 01/29/1993

(268) The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry ODE 1332 10/04/2002

(269) Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 ODE 352 01/01/1990

(270) Toxicology Risk Assessment Committee #G89-1 (blue book memo) ODE 363 08/09/1989

(271) Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA ODE 361 08/30/2002

(272) Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo) ODE 164 05/01/1995

(273) Draft Guidance for Industry and FDA Staff—Functional Indications for Implantable Cardioverter Defibrillators ODE OC 1304 10/06/2005

(274) Guidance for Industry—Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software ODE OC 1553 01/14/2005

(275) Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities ODE/DAGID 1833 09/19/1995

(276) Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA ODE/DAGID 1178 07/17/2002

(277) Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA ODE/DAGID 1203 04/22/2003

(278) Dental Cements—Premarket Notification; Final ODE/DAGID 2204 08/18/1998

(279) Dental Impression Materials—Premarket Notification; Final ODE/DAGID 2203 08/17/1998

(280) Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices ODE/DAGID 1216 06/01/2004

(281) Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities ODE/DAGID 833 03/01/1993

(282) Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints ODE/DAGID 993 12/01/1995

(283) OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final ODE/DAGID 2205 08/17/1998

(284) Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft ODE/DAGID 1156 02/08/2000

(285) Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices; Final ODE/DAGID/ARDB 1138 07/03/2000

(286) Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA ODE/DAGID/ARDB 1335 12/13/2002

(287) Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA ODE/DAGID/ARDB 1126 10/05/2001

(288) Draft 510(K) Submission Requirements for Peak Flow Meters ODE/DAGID/ARDB 999 01/13/1994

(289) Draft Emergency Resuscitator Guidance ODE/DAGID/ARDB 985 04/14/1993

(290) Draft Reviewer Guidance for Ventilators ODE/DAGID/ARDB 500 07/01/1995

(291) Draft Reviewer Guidance on Face Masks and Shield for CPR ODE/DAGID/ARDB 996 03/16/1994

(292) Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI standard) ODE/DAGID/ARDB 638 11/01/1993

(293) General Guidance Document: Non-Invasive Pulse Oximeter ODE/DAGID/ARDB 997 09/07/1992

(294) Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final ODE/DAGID/ARDB 1157 01/24/2000

(295) Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II ODE/DAGID/ARDB 583 02/01/1989

(296) Guidance for Peak Flow Meters for Over-the-Counter Sale ODE/DAGID/ARDB 998 06/23/1992

(297) Heated Humidifier Review Guidance ODE/DAGID/ARDB 780 08/30/1991

(298) Review Guidance for Oxygen Generators and Oxygen Equipment ODE/DAGID/ARDB 986

(299) Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators ODE/DAGID/ARDB 784 10/01/1993

(300) Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices—Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1393 12/02/2003

(301) Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA ODE/DAGID/DEDB 1378 11/12/2002

(302) Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments—Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1389 05/12/2004

(303) Dental Bone Grafting Material Devices—Class II Special Controls Guidance Document—Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1512 04/28/2005

(304) Dental Composite Resin Devices—Premarket Notification [510(k)] Submissions—Guidance for Industry and FDA Staff ODE/DAGID/DEDB 642 10/26/2005

(305) Guidance Document on Dental Handpieces ODE/DAGID/DEDB 556 07/01/1995

(306) Guidance for Industry and FDA Staff—Class II Special Controls Document: Oral Rinse to Reduce the Adhesion of Dental Plaque ODE/DAGID/DEDB 1559 09/20/2005

(307) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys ODE/DAGID/DEDB 1416 08/23/2004

(308) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys ODE/DAGID/DEDB 1415 08/23/2004

(309) Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA ODE/DAGID/DEDB 1192 02/20/2002

(310) Class II Special Controls Guidance document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information—Guidance for Industry and FDA Staff ODE/DAGID/GHDB 1541 12/10/2004

(311) Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA ODE/DAGID/GHDB 1326 03/12/2001

(312) Guidance for Industry and FDA Review Staff—Intravascular Administration Sets Premarket Notification Submissions [510(k)] ODE/DAGID/GHDB 1189 04/15/2005

(313) Guidance on 510(k) Submissions for Implanted Infusion Ports ODE/DAGID/GHDB 392 10/01/1990

(314) Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters ODE/DAGID/GHDB 824 03/16/1995

(315) Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers ODE/DAGID/GHDB 822 03/01/1993

(316) Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps ODE/DAGID/GHDB 823 03/01/1993

(317) Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles ODE/DAGID/GHDB 450 04/01/1993

(318) Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes ODE/DAGID/GHDB 821 04/01/1993

(319) Medical Devices with Sharps Injury Prevention Features—Guidance for Industry and FDA Staff ODE/DAGID/GHDB 934 08/09/2005

(320) Neonatal and Neonatal Transport Incubators—Premarket Notifications; Final ODE/DAGID/GHDB 2201 09/18/1998

(321) CDRH Regulatory Guidance for Washers and Washer-Disinfectors Intended for use in Processing Reusable Medical Devices ODE/DAGID/INCB 4 06/02/1998

(322) Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff ODE/DAGID/INCB 1252 02/07/2002

(323) Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities ODE/DAGID/INCB 881 08/01/1993

(324) Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes ODE/DAGID/INCB 888 08/01/1993

(325) Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final ODE/DAGID/INCB 397 01/03/2000

(326) Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers ODE/DAGID/INCB 895 10/01/1993

(327) Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's Glove—Guidance for Industry and FDA Staff ODE/DAGID/INCB 1230 04/13/2004

(328) Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA ODE/DAGID/INCB 891 03/02/2001

(329) Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA ODE/DAGID/INCB 1388 03/07/2002

(330) Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; Final ODE/DAGID/INCB 944 01/13/199

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