Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal RegisterAug 9, 2010
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1998-N-0050] (formerly Docket No. 1998N-0046)
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 a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). 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 It also provides information on guidance documents that have been added or withdrawn in the past 5 years.
DATES:
We welcome general comments on this list and on agency guidance documents at any time.
ADDRESSES:
Submit electronic comments to
http://www.regulations.gov
. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For information on a specific guidance or to obtain a paper copy, please refer to each Center's section of this document.
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 (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.
FDA has adopted a new format for the publication of its comprehensive guidance list. This new format is intended to increase the timeliness of the comprehensive list. For information on a specific guidance or to obtain a paper copy, please refer to each Center's section of this document. The lists of guidance documents are either a printout of FDA's Web site as of April 2010 or a list compiled by the issuing office. You should note that some guidance documents pertain to more than one product area (e.g., drugs and biologics), and are, therefore, listed under both Centers involved or pertain to more than one subject matter (e.g., “Food Defense and Emergency Response” and “Imports”), and are, therefore, listed under more than one category within a Center. So there may be some duplication in the guidance lists. 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 guidance 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.
II. Center for Biologics Evaluation and Research (CBER)
For information a specific guidance document or to obtain a paper copy, contact:
Office of Communication, Outreach, and Development, 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, e-mail:
ocod@fda.hhs.gov
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
.
The following is a list of CBER guidance documents that have been withdrawn:
Title of Document
Date of Issuance
Date of Withdrawal
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing
3/15/2000
4/10/2006
Draft 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
4/11/2006
Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research
8/23/2001
August 9, 2010.
The following list of current CBER guidance documents was obtained from FDA's Web site on April 20, 2010:
Administrative
• Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (PDF - 316KB)
9/2009
• Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB)
5/2009
• Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
1/2009
• Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
9/15/2005
• Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria
10/4/2004
• Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
5/28/2004
• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
5/21/2004
• Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
11/24/2003
• Premarket Approval Application Modular Review
11/3/2003
Adverse Events and Product Deviation Guidances
• Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs—Improving Human Subject Protection (PDF - 61KB)
1/2009
• Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF - 246KB)
12/2008
• Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports (PDF - 107KB)
6/2008
• Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
10/2006
• Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 52KB)
1/2006
• Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF - 375KB)
3/2001
• Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95KB)
8/1997
Allergenic Guidance Documents
• Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
11/20/2008
• Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
11/20/2000
• 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
Application Submissions
• Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
2/2010
• SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
10/2009
• Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB)
10/2009
• Providing Regulatory Submissions in Electronic Format—(PDF - 123KB)
5/2009
• Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
12/2008
• Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
11/2008
• Tropical Disease Priority Review Vouchers (PDF - 112KB)
10/2008
• Integrated Summary of Effectiveness (PDF - 95KB)
8/2008
• Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 121KB)
8/2008
• Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports (PDF - 107KB)
6/2008
• Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 133KB)
6/2008
• Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
6/2008
• Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
2/2008
• Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF Version) (PDF - 127KB)
2/2008
• Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols (PDF - 76KB)
11/2007
• In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions (PDF - 268KB)
10/2007
• Pharmacogenomic Data Submissions—Companion Guidance (PDF - 211KB)
8/2007
• Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission (PDF Version) (PDF - 145KB)
6/2007
• Providing Regulatory Submissions in Electronic Format—Receipt Date (PDF - 59KB)
6/2007
• Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) (PDF Version) (PDF - 127KB)
10/2006
• Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF Version) (PDF - 82KB)
4/2006
• Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB)
2/2006
• Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF - 295KB)
2/2006
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110KB)
2/2006
• Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB)
2/2006
• How to Comply with the Pediatric Research Equity Act (PDF - 116KB)
9/2005
• Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
5/2005
• Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF version) (PDF - 342KB)
5/2005
• Providing Regulatory Submissions in Electronic Format—Content of Labeling (PDF - 28KB)
4/2005
• Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB)
4/2005
• Pharmacogenomic Data Submissions (PDF - 96KB)
3/2005
• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211KB)
12/2004
• Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
11/2004
• Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria (PDF Version) (PDF - 175KB)
10/2004
• Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) (PDF Version) (PDF - 109KB)
5/2004
• Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
5/2004
• Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (PDF Version) (PDF - 87KB)
11/2003
• Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF - 159KB)
11/2003
• Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)
10/2003
• Part 11, Electronic Records; Electronic Signatures—Scope and Application (PDF - 215KB)
8/2003
• Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF - 529KB)
5/2003
• 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
2/2003
• Comparability Protocols—Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
2/2003
• Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff - PDF (PDF - 548KB)
2/2003
• Special Protocol Assessment (PDF - 36KB)
5/2002
• Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs) (PDF) (PDF - 80KB)
3/2002
• Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
10/2001
• Draft Guidance for Industry - Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research
9/2001
• Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF - 50KB)
8/2001
• Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF - 32KB)
4/2001
• Acceptance of Foreign Clinical Studies (PDF - 12KB)
3/2001
• Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
11/2000
• Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
10/2000
• Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (PDF - 14KB)
10/2000
• Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 30KB)
2/2000
• Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)
2/2000
• Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 57KB)
9/1999
• Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43KB)
8/1999
• Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications (PDF - 582KB)
11/1999
• Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF - 62KB)
10/1998
• Submitting Debarment Certification Statements (PDF - 144KB)
9/1998
• Standards for Prompt Review of Efficacy Supplements (PDF - 76KB)
5/1998
• Classifying Resubmissions in Response to Action Letters (PDF - 76KB)
4/1998
• Pediatric Use Supplements—Content and Format (PDF - 24KB)
5/1996
• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF - 41KB)
11/1995
• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
11/1995
• FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability (PDF - 34KB)
7/1995
• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB)
11/1994
• Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
3/1991
• Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007
Blood Guidance Documents
• Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009 (PDF - 858KB)
10/2009, Updated: 12/2009
• Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (PDF - 80KB)
11/13/2009
• Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion (PDF - 68KB)
11/6/2009
• Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 91KB)
10/2009
• Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
10/2009
• Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection
8/2009
• Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products
7/28/2009
• Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products
3/2009
• Assay Migration Studies for In Vitro Diagnostic Devices
1/5/2009
• Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
7/17/2008
• Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
5/20/2008
• Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
4/25/2008
• Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
12/17/2007
• Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
11/29/2007
• Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
11/21/2007
• Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
10/26/2007
• Guidance for Industry: “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV
8/24/2007
• Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
8/08/2007
• Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
6/20/2007
• Draft Guidance for Industry: “Computer Crossmatch” (Electronic Based Testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)
6/20/2007
• Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
10/27/2006
• Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
10/18/2006
• Guidance for Industry: Bar Code Label Requirements - Questions and Answers
10/5/2006
• Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
9/22/2006
• United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (PDF - 1665KB)
9/22/2006
• Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
8/08/2006
• Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to “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”
8/08/2006
• 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
• 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
• 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)
11/24/2004
• Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
11/30/2004
• 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
• 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”
1/22/2004
• Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Guidance for Industry and FDA Staff
10/30/2003
• 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: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires
7/3/2003
• Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis
6/25/2003
• 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”
4/25/2003
• 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
• 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”
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 Vaccine Recipients
12/30/2002
• 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
• 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
• Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
11/22/2001
• 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
• Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis
8/22/2001
• Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
8/07/2001
• 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
• 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: Monoclonal Antibodies Used as Reagents in Drug Manufacturing
3/29/2001
• Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001
2/13/2001
• Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion
1/23/2001
• Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
6/23/2000
• Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria
6/8/2000
• 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: 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: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB)
7/15/1999
• 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: 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
• Withdrawal of “Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)”
9/8/1998
• Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing
6/11/1998
• 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: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products
1/08/1998
• Guidance for Industry: Donor Screening for Antibodies to HTLV-II
8/15/1997
• Guidance for Industry: Changes to an Approved Application: Biological Products (PDF - 39KB)
7/1997
• Guideline for Quality Assurance in Blood Establishments (PDF - 77KB)
7/11/1995
• Draft Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2101KB)
3/1992
• Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin (PDF - 1161KB)
3/1992
• Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin (PDF - 211KB)
1992
• Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (“High Risk” Donors) (PDF - 176KB)
10/26/1989
• Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1 (PDF - 1784KB)
8/08/1989
• 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 (PDF - 2874KB)
12/1987
• Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1189KB)
8/1985
• Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (PDF - 368KB)
6/1980
Cellular & Gene Therapy Guidance Documents
• Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 91KB)
10/2009
• Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
10/2009
• Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
9/2009
• Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
09/2009
• Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease
03/2009
• Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
10/9/2008
• Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
4/9/2008
• Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
4/9/2008
• Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products
2/11/2008
• Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
8/8/2007
• Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
7/6/2007
• Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events
11/28/2006
• 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
11/28/2006
• Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy
3/30/1998
• Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products (TXT - 59KB)
01/1997
CMC & GMP
• Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
2/2010
• Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (PDF - 91KB)
11/2008
• Process Validation: General Principles and Practices (PDF - 194KB)
11/2008
• Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)
7/2008
• Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms (PDF - 184KB)
9/6/2007
• Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 443KB)
9/2006
• Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF - 253KB)
9/2006
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110KB)
1/2006
• Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
5/2005
• Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice (PDF - 734KB)
9/2004
• Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82KB)
9/2003
• Comparability Protocols—Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
2/2003
• CVM GFI #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB)
9/2002
• Container Closure Systems for Packaging Human Drugs and Biologics—Questions and Answers (PDF - 15KB)
5/2002
• IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB)
5/2001
• Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 30KB)
3/2001
• Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation (PDF - 91KB)
8/2000
• Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
8/1999
• Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)
5/1999
• Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)
7/1998
• Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
3/1998
• 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 (PDF - 44KB)
8/1996
• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB)
11/1994
• 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 (PDF - 2874KB)
12/1987
• Guidance on Alternatives to Lot Release for Licensed Biological Products (PDF - 305KB)
7/14/1993
Clinical
• Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)
7/2009
• Postmarketing Studies and Clinical Trials—Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (PDF - 173KB)
7/2009
• The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 421KB)
6/2009
• Animal Models—Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB)
2/2009
• Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs—Improving Human Subject Protection (PDF - 61KB)
1/2009
• Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145KB)
5/2007
• Computerized Systems Used in Clinical Trials (PDF - 53KB)
5/2007
• Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF - 253KB)
9/2006
• Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment (PDF - 205KB)
6/2006
• Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
4/25/2006
• The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors
3/2006
• Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB)
3/2006
• Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB)
2/2006
• Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 127KB)
2/2006
• Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70KB)
9/2005
• Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (PDF - 702KB)
7/2005
• Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3151KB)
4/2005
• Premarketing Risk Assessment (PDF - 88KB)
3/2005
• Development and Use of Risk Minimization Action Plans (PDF - 225KB)
3/2005
• Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
3/2005
• Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB)
2/2005
• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211KB)
12/2004
• Available Therapy (PDF - 176KB)
7/2004
• Vaccinia Virus—Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB)
3/2004
• Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 40KB)
1/2004
• IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 188KB)
1/2004
• Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version) (PDF - 389KB)
7/2003
• Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222KB)
5/2003
• Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications (PDF - 221KB)
4/2003
• Establishing Pregnancy Exposure Registries (PDF - 268KB)
8/2002
• Special Protocol Assessment (PDF - 36KB)
5/2002
• FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB)
11/2001
• Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
10/2001
• IDE Financial Disclosure
• Acceptance of Foreign Clinical Studies (PDF - 12KB)
3/2001
• Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
11/2000
• Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
10/2000
• Pediatric Oncology Studies In Response to a Written Request (PDF - 30KB)
6/2000
• In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44KB)
11/2009
• Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB)
7/1999
• Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369KB)
2/1999
• Population Pharmacokinetics (PDF - 135KB)
2/1999
• FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58KB)
12/1998
• General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF - 37KB)
11/1998
• Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129KB)
5/1998
• Pharmacokinetics in Patients with Impaired Renal Function (PDF - 128KB)
5/1998
• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
11/1995
Devices
• Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (PDF - 388KB)
• Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria (PDF Version) (PDF - 175KB)
• Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) (PDF Version) (PDF - 109KB)
• Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 112KB)
• Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
• Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
• Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
• Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 196KB)
• Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
• Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF Version) (PDF - 127KB)
• In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions (PDF - 268KB)
• Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version) (PDF - 139KB)
• In Vitro Diagnostic Multivariate Index Assays (PDF version) (PDF - 72KB)
• Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission (PDF Version) (PDF - 145KB)
• Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) (PDF Version) (PDF - 127KB)
• Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF version) (PDF - 342KB)
• Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 127KB)
• Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
• Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF Version) (PDF - 82KB)
• Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
• Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
• Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version) (PDF - 389KB)
• Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
• Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF - 159KB)
• Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF - 529KB)
• 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
• Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff - PDF (PDF - 548KB)
• Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria (PDF Version) (PDF - 175KB)
Labeling & Promotion
• Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (PDF - 163KB)
• Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
• Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF - 295KB)
• Labeling for Human Prescription Drug and Biological Products—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 65KB)
• Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387KB)
• Indexing Structured Product Labeling (PDF - 59KB)
• Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version) (PDF - 139KB)
• Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 52KB)
• Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 127KB)
• Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 58KB)
• Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements (PDF - 213KB)
• Providing Regulatory Submissions in Electronic Format—Content of Labeling (PDF - 28KB)
• Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB)
• Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use (PDF Version) (PDF - 1385KB)
• Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB)
• “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (PDF - 188KB)
• Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222KB)
• Content and Format for Geriatric Labeling (PDF - 38KB)
• Prescription Drug Advertising and Promotional Labeling (PDF - 28KB)
• In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44KB)
• Consumer-Directed Broadcast Advertisements (PDF - 36KB)
• Accelerated Approval Products—Submission of Promotional Materials (PDF - 17KB)
• Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB)
• Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979KB)
Tissue Guidance Documents
• Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products
3/2009
• Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
1/16/2009
• Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide
8/24/2007
• Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
7/6/2007
• Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
9/20/2006
• Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation
3/8/2002
• Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
4/25/2008
• Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests
4/16/2008
• Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
8/8/2007
• 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
• Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
6/23/2000
• Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1)—Manufacturing Arrangements
9/8/2006
• 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: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
7/23/2007
• Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
1/31/2007
• Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
1/16/2007
• Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation (PDF - 59KB)
Vaccine Guidance Documents
• Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (PDF - 406KB)
3/2010
• Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
09/2009
• Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases
9/8/2008
• Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
10/29/2007
• Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
9/27/2007
• Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
5/31/2007
• Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
5/31/2007
• Draft Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
9/28/2006
• Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
5/4/2006
• Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
2/13/2006
• Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
2/17/2005
• Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
10/1/2004
• Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
3/12/2001
• Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
11/20/2000
• Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications
9/8/2000
• 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
• Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) (PDF - 63KB)
9/8/1998
• Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies (PDF - 49KB)
4/10/1997
Xenotransplantation Guidance Documents
• Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
4/3/2003
• 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
• PHS Guideline on Infectious Disease Issues in Xenotransplantation
1/19/2001
• Guidance For Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans
4/6/1999
III. Center for Drug Evaluation and Research (CDER)
For information on a specific guidance document or to obtain a paper copy, contact:
Division of Drug Information, Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993, 1-888-463-6332 or 301-796-3400, e-mail:
druginfo@fda.hhs.gov
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm
.
The following list of withdrawn CDER guidance documents was obtained from FDA's Web site on April 21, 2010:
Title
Subject
Level at Date
of Issue
Publication/
Withdrawal Date
Status
Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products under PDUFA
Procedural
Level 1
04/09/2010
Withdrawn
Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA
Procedural
Level 1
04/09/2010
Withdrawn
Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA; Paperwork Reduction Act Burden Statement
Procedural
Level 1
04/09/2010
Withdrawn
Clinical Evaluation of Lipid-Altering Agents
Clinical Medical Draft
Level 1
04/16/2010
Withdrawn
The following list of current CDER guidance documents was obtained from FDA's Web site on April 21, 2010:
Title and Format
Type
Issue Date
Advertising
Accelerated Approval Products: Submission of Promotional Materials (PDF - 17 KB)
Draft
3/26/1999
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling (PDF - 84 KB)
Final
12/1997
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192 KB)
Draft
2/4/2004
• Labeling Example (PDF - 105 KB)
• Labeling Example; Consumer-Friendly Version (PDF - 95KB)
Consumer-Directed Broadcast Advertisements (PDF - 36KB)
Questions and Answers (PDF - 83 KB)
Final
8/1999
Consumer-Directed Broadcast Advertising of Restricted Devices (PDF - 41 KB)
Draft
1/26/2004
“Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (PDF - 188 KB)
Draft
1/26/2004
Industry-Supported Scientific and Educational Activities (PDF - 429 KB)
Final
12/3/1997
Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387 KB)
Draft
5/26/2009
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB)
Draft
1/1999
Biopharmaceutics
Bioanalytical Method Validation (PDF - 63 KB)
Final
5/2001
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (PDF - 519 KB)
Draft
4/2/2003
4/11/2003
• Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data (PDF - 186 KB)
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (PDF - 268 KB)
Final
3/2003
Cholestyramine Powder in Vitro Bioequivalence (PDF - 35 KB) (Intermin Guidance)
Final
7/15/93
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing (PDF - 78 KB)
Final
6/17/2005
Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence.
Draft
Withdrawn
FR Notice
8/12/2005
Corticosteroids, Dermatologic (topical) In Vivo (PDF - 3 MB) (Issued 6/2/1995, Posted 3/6/1998)
Final
6/2/1995
Dissolution Testing of Immediate Release Solid Oral Dosage Forms (PDF - 130 KB) (Issued 8/1997, Posted 8/25/1997)
Final
8/1997
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (PDF - 170 KB)
Final
9/1997
Food-Effect Bioavailability and Fed Bioequivalence Studies(PDF - 166 KB)
Final
12/2002
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (PDF - 744 KB)
Final
6/27/1989
Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing (PDF - 718 KB)
Final
6/6/1994
Statistical Approaches to Establishing Bioequivalence (PDF - 130 KB)
Final
2/2001
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.(PDF - 143 KB).
Final
8/2000
CMC - Microbiology (Chemistry, Manufacturing, and Controls)
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57 KB)
Final
11/1994
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 76 KB)
Final
2/25/2010
Chemistry, Manufacturing, and Controls (CMC)
Analytical Procedures and Methods Validation.(PDF - 91 KB)
Draft
8/2000
Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161 KB)
Draft
12/3/2009
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation 2/2001
Final
Withdrawn as per FR notice June 1, 2006
Botanical Drug Products (PDF - 437 KB)
Final
6/2004
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF - 33 KB)
Final
7/1997
Changes to an Approved NDA or ANDA (PDF - 108 KB)
Final
4/2004
Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35 KB)
Final
1/2001
Changes to an Approved NDA or ANDA; Specifications—Use of Enforcement Discretion for Compendial Changes (PDF - 18 KB)
Final
11/19/2004
Comparability Protocols—Chemistry, Manufacturing, and Controls Information (PDF - 240 KB)
Draft
2/2003
Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164 KB)
Final
5/1999
• [Container Closure Systems for Packaging Human Drugs and Biologics—Questions and Answers (PDF - 15 KB)
5/2002
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
Final
4/1996
Development of New Stereoisomeric Drugs
Final
5/1/1992
Drug Master Files
Current DMF Information(e.g. lists, addresses, guidances, etc.)
Final
9/1/1989
Drug Master Files for Bulk Antibiotic Drug Substances (PDF - 23 KB)
Final
11/1999
Drug Product: Chemistry, Manufacturing, and Controls Information 1/2003
Draft
Withdrawn as per FR notice June 1, 2006
Drug Substance: Chemistry, Manufacturing, and Controls Information 1/2004
Draft
Withdrawn as per FR notice June 1, 2006
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88 KB)
Draft
9/11/2003
Environmental Assessment of Human Drug and Biologics Applications (PDF - 188 KB)
Final
7/1998
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* 2/1987
Final
Withdrawn as per FR notice June 1, 2006
Format and Content for the CMC Section of an Annual Report (PDF - 29 KB)
Final
9/1/1994
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 79 KB)
Draft
7/13/2009
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF - 193 KB)
Final
5/20/2003
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30 KB)
Final
5/2001
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26 KB)
Draft
7/24/1999
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.(PDF - 45 KB)
Draft
7/2002
Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 29 KB)
Final
3/2001
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (PDF - 361 KB)
Draft
11/13/1998
Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF - 116 KB)
Final
7/2002
NDAs: Impurities in Drug Substances (PDF - 11 KB)
Final
2/2000
Orally Disintegrating Tablets (PDF - 52 KB)
Final
12/17/2008
PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (PDF - 76 KB)
Final
4/28/1998
Residual Solvents in Drug Products Marketed in the United States (PDF - 52 KB)
Final
11/24/2009
Reviewer Guidance, Validation of Chromatographic Methods (PDF - 703 KB) (revised to include graphics, 5/14/2007)
Final
11/1994
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE)(PDF - 790 KB)
Final
12/20/2000
Stability Testing of Drug Substances and Drug Products 6/5/1998
Draft
Withdrawn as per FR notice June 1, 2006
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances 11/1994
Final
Withdrawn as per FR notice June 1, 2006
Submitting Documentation for the Manufacturing of and Controls for Drug Products*(PDF - 1.02 MB)
Final
2/1987
Submitting Documentation for the Stability of Human Drugs and Biologics* (Issued , Posted 3/2/1998)
Final
Withdrawn as per FR notice June 1, 2006
Submitting Samples and Analytical Data for Methods Validation
Final
2/1987
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (PDF - 94 KB)
Final
2/1987
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 (PDF - 60 KB)
Final
11/1995
SUPAC-IR Questions and Answers about SUPAC-IR Guidance
Final
2/18/1997
SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (PDF - 117 KB)
Final
1/1999
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 (PDF - 215 KB)
Final
Issued 10/6/1997
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (PDF - 61 KB)
Draft
12/1998
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 (PDF - 118 KB)
Final
5/1997
Clinical / Antimicrobial
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment(PDF - 422 KB)
Draft
8/21/2008
Acute Bacterial Meningitis—Developing Antimicrobial Drugs for Treatment(PDF - 42 KB)
Draft
7/22/1998
Acute Bacterial Sinusitis—Developing Antimicrobial Drugs for Treatment (PDF - 155 KB)
Draft
10/29/2007
Acute or Chronic Bacterial Prostatitis—Developing Antimicrobial Drugs for Treatment (PDF - 42 KB)
Draft
7/22/1998
Acute Bacterial Otitis Media: Developing Drugs for Treatment (PDF - 173 KB)
Draft
1/17/2008
Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval (PDF - 41 KB)
Draft
10/12/2007
Antiviral Product Development—Conducting and Submitting Virology Studies to the Agency (PDF - 208 KB)
Final
6/2/2006
• Guidance for Submitting HIV Resistance Data (PDF - 293 KB)
• Guidance for Submitting Influenza Resistance Data (PDF - 385 KB)
• Guidance for Submitting HBV Resistance Data (PDF - 123 KB)
• Guidance for Submitting HCV Resistance Data (PDF - 122 KB)
Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval (PDF - 254 KB)
Final
10/2002
Bacterial Vaginosis—Developing Antimicrobial Drugs for Treatment (PDF - 53 KB)
Draft
7/22/1998
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs for Treatment (PDF - 54 KB)
Draft
10/1999
Clinical Development and Labeling of Anti-Infective Drug Products (PDF - 5 MB)
Final
10/1992 Revised 2/12/2001
Clinical Evaluation of Anti-Infective Drugs (Systemic)(PDF - 1 MB)
Final
9/77
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment (PDF - 418 KB)
Draft
3/19/2009
Complicated Urinary Tract Infections and Pyelonephritis—Developing Antimicrobial Drugs for Treatment (PDF - 35 KB)
Draft
7/22/1998
Developing Antimicrobial Drugs—General Considerations for Clinical Trials (PDF - 134 KB) [Main Document]
Draft
7/22/1998
Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post Exposure)—(PDF - 51 KB)
Draft
3/15/2002
Empiric Therapy of Febrile Neutropenia—Developing Antimicrobial Drugs for Treatment (PDF - 33 KB)
Draft
7/22/1998
Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (PDF - 267 KB)
Draft
2/18/1997
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (PDF - 145 KB)
Draft
10/2/2009
Influenza: Developing Drugs for Treatment and/or Prophylaxis(PDF - 225 KB)
Draft
2/19/2009
Lyme Disease—Developing Antimicrobial Drugs for Treatment (PDF - 42 KB)
Draft
7/22/1998
Microbiological Data for Systemic Antibacterial Drug Products—Development, Analysis, and Presentation (PDF - 272 KB)
Draft
9/16/2009
Nosocomial Pneumonia—Developing Antimicrobial Drugs for Treatment (PDF - 49 KB)
Draft
7/22/1998
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (PDF - 244 KB)
Final
10/30/2007
Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment (PDF - 10 KB)
Draft
7/22/1998
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF - 257 KB)
Draft
11/21/2007
Streptococcal Pharyngitis and Tonsillitis—Developing Antimicrobial Drugs for Treatment (PDF - 29 KB)
Draft
7/22/1998
Uncomplicated and Complicated Skin and Skin Structure Infections—Developing Antimicrobial Drugs for Treatment (PDF - 49 KB)
Draft
7/22/1998
Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment (PDF - 30 KB)
Draft
7/22/1998,
Uncomplicated Urinary Tract Infections—Developing Antimicrobial Drugs for Treatment (PDF - 42 KB)
Draft
7/22/1998
Vaccinia Virus—Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139 KB)
Draft
3/8/2004
Vulvovaginal Candidiasis—Developing Antimicrobial Drugs for Treatment (PDF - 42 KB)
Draft
7/22/1998
Clinical / Medical
Acceptance of Foreign Clinical Studies (PDF - 12 KB)
Final
3/12/2001
Acne Vulgaris: Developing Drugs for Treatment (PDF - 284 KB)
Draft
9/16/2005
Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 424 KB)
Draft
2/25/2010
Allergic Rhinitis: Clinical Development Programs for Drug Products (PDF - 68 KB)
Draft
6/2000
Antianxiety Drugs—Clinical Evaluation (PDF - 2 MB)
Final
9/1977
Antidepressant Drugs—Clinical Evaluation (PDF - 2 MB)
Final
9/1977
Assessment of Abuse Potential of Drugs (PDF - 138 KB)
Draft
1/26/2010
Available Therapy (PDF - 176 KB)
Final
7/22/2004
Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug Application (PDF - 157 KB)
Final
8/13/2004
Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39 KB)
Final
10/11/2001
Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment(PDF - 205 KB)
Final
6/1/2006
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (PDF - 153 KB)
Draft
11/8/2007
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40 KB)
Draft
7/07/1999
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369 KB)
Final
1/1999
Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice)
Final
Withdrawn
8/5/2003
Clinical Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Final
Withdrawn
7/20/2004
Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children)
Final
Withdrawn
5/29/2008
Clinical Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Final
Withdrawn
Withdrawn
7/20/2004
Clinical Evaluation of Antiepileptic Drugs (adults and children) (PDF - 1,007 KB)
Final
1/1981
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Final
Withdrawn
Withdrawn
7/20/2004
Clinical Evaluation of General Anesthetics (PDF - 890 KB)
Final
5/1982
Clinical Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Final
Withdrawn
Withdrawn
7/20/2004
Clinical Evaluation of Lipid-Altering Agents (PDF - 36 KB)
Draft
Withdrawn
4/19/2010
Clinical Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Final
Withdrawn
Withdrawn
7/20/2004
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145 KB)
Final
5/15/2007
Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70 KB)
Final
9/16/2005
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42 KB)
Final
11/1995
○ Questions and Answers: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (PDF - 14 KB) (10/2000)
Developing Medical Imaging Drug and Biological Products
Final
6/17/2004
• Part 1: Conducting Safety Assessments (PDF - 271 KB)
• Part 2: Clinical Indications (PDF - 231 KB)
• Part 3: Design, Analysis, and Interpretation of Clinical Studies(PDF - 307 KB)
Developing Products for Weight Management Revision 1 (PDF - 150 KB)
Draft
2/14/2007
Development and Use of Risk Minimization Action Plans (PDF - 225 KB)
Final
3/24/2005
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (PDF - 20 KB)
Draft
5/2000
Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (PDF - 265 KB)
Draft
2/29/2008
Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes (PDF - 51 KB)
Final
12/17/2008
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88 KB)
Draft
9/6/2002
Establishing Pregnancy Exposure Registries (PDF - 268 KB)
Final
8/2002
Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF - 333 KB)
Final
3/27/2006
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Recommendations for Clinical Evaluation (PDF - 198 KB)
Draft
1/2003
Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3 MB)
Final
4/27/2005
Exercise-Induced Bronchospasm (EIB)—Development of Drugs to Prevent EIB (PDF - 27 KB)
Draft
2/2002
Exocrine Pancreatic Insufficiency Drug Products—Submitting New Drug Applications(PDF - 149 KB)
Final
4/13/2006
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment (PDF - 23 KB)
Draft
5/2000
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58 KB)
Final
12/1998
FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (PDF - 2 MB)
Final
Posted 3/2/1998
FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July 20, 2004, Federal Register notice.)
Final
Withdrawn
Withdrawn
7/20/2004
Format and Content of the Clinical and Statistical Sections of an Application (PDF - 1 MB)
Final
7/1988
Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (PDF - 2 MB)
Final
2/1987
General Considerations for the Clinical Evaluation of Drugs (PDF - 1 MB)
Final
General Considerations for the Clinical Evaluation of Drugs in Infants and Children (PDF 2 MB)
Final
9/77
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (PDF -91KB)
Draft
6/24/ 2005
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220 KB)
Final
3/24/2005
Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF - 333KB)
Final
3/27/2006
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (PDF - 2 MB)
Draft
8/29/2006
Guidance for the Development of Vaginal Contraceptive Drugs (NDA)(PDF - 465 KB)
Final
3/2/1998
Hypnotic Drugs—Clinical Evaluation (PDF - 2MB)
Final
9/77
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 188 KB)
Final
Revised
1/15/2004
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (PDF - 27 KB)
Draft
7/2002
Integration of Dose-Counting Mechanisms into MDI Drug Products (PDF - 126 KB)
Final
3/2003
Internal Radioactive Contamination—Development of Decorporation Agents (PDF - 177 KB)
Final
3/1/2006
Irritable Bowel Syndrome—Clinical Evaluation of Products for Treatment (PDF 221 KB)
Draft
3/22/2010
Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (PDF - 27 KB)
Final
2/2001
Local Anesthetics—Clinical Evaluation (PDF - 1 MB
Final
3/2/1998
Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis (PDF - 344 KB)
Draft
6/6/2007
MDI and DPI Drug Products—Clinical Development Programs for (PDF - 699 KB)
Final
9/19/1994
Non-Inferiority Clinical Trials (PDF - 565 KB)
Draft
2/26/2010
Pediatric Use Supplements—Content and Format (PDF - 24 KB)
Final
5/1996
Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer (PDF - 2 MB)
Final
Posted
3/2/1998
Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children (PDF - 247 KB)
Final
3/5/2007
OTC Treatment of Herpes Labialis with Antiviral Agents (PDF - 15 KB)
Draft
Withdrawn
3/18/2010
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF -295 KB)
Final
12/8/2009
Pediatric Oncology Studies In Response to a Written Request (PDF - 30 KB)
Draft
6/2000
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95 KB)
Final
8/27/1997
Postmarketing Reporting of Adverse Drug Experiences (PDF - 7 MB)
Final
3/1992
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis (PDF - 50 KB) Withdrawn
Draft
Withdrawn
Withdrawn
12/2009
Premarketing Risk Assessment(PDF - 88 KB)
Final
3/24/2005
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129 KB)
Final
5/14/1998
Prussian Blue Drug Products—Submitting a New Drug Application (PDF - 178 KB)
Final
1/2003
Psychoactive Drugs in Infants and Children—Clinical Evaluation (PDF - 18 MB)
Final
3/2/1998
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 421 KB)
Draft
6/2/2009
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56 KB)
Draft
Posted
12/1/2000
Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment (PDF - 113 KB)
Draft
Posted
11/21/2006
Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (PDF - 2 MB)
Final
7/22/1993
Study of Drugs Likely to be used in the Elderly (PDF - 1MB)
Final
11/1989
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43 KB)
Final
8/1999
Summary for New Drug and Antibiotic Applications—Format and Content of the Summary for New Drug and Antibiotic Applications (PDF - 1 MB)
Final
2/1987
Systemic Lupus Erythematosus—Developing Drugs for Treatment (PDF - 403 KB)
Draft
3/28/2005
The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 33 KB)
Final
9/2004
Waiver of IRB Requirements for Drug and Biological Product Studies (PDF - 33 KB)
Final
1/2006
Clinical Pharmacology
Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363 KB)
Draft
Issued
2/7/05
Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF - 253 KB)
Draft
Issued
9/11/2006
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (PDF - 109 KB)
Final
4/1997
Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications (PDF - 221 KB)
Final
5/5/2003
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (PDF - 519 KB)
Final
2/1987
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF - 37 KB)
Draft
11/1998
In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44 KB)
Final
11/24/1999
Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 151 KB)
Draft
3/17/2010
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222 KB)
Final
Posted
5/30/2003
Pharmacokinetics in Patients with Impaired Renal Function (PDF - 128 KB)
Final
5/14/1998
Pharmacokinetics in Pregnancy—Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 324 KB)
Draft
10/29/2004
Population Pharmacokinetics (PDF - 135 KB)
Final
2/1999
Combination Products
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (PDF - 120 KB)
• Coronary Drug-Eluting Stents—Nonclinical and Clinical Studies -Companion Document (PDF - 295 KB)
Current Good Manufacturing Practices (CGMPs)/Compliance
Bar Code Label Requirements—Questions and Answers (PDF - 101 KB)
Final
10/5/2006
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82 KB)
Draft
9/3/2003
Compressed Medical Gases
Final
2/1989
Computerized Systems Used in Clinical Investigations (PDF - 53 KB)
Final
5/10/2007
Current Good Manufacturing Practice for Combination Products (PDF - 350 KB)
Draft
9/29/2004
Current Good Manufacturing Practice for Medical Gases (PDF - 437 KB)
Draft
5/6/2003
Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132 KB)
Final
7/14/2008
Dosage Delivery Devices for OTC Liquid Drug Products (PDF -93 KB)
Draft
11/04/2009
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF - 88 KB)
Final
6/27/1997
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 19 KB)
Draft
5/27/2005
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110 KB)
Final
1/11/2006
General Principles of Process Validation
Final
5/1987
Good Laboratory Practice Regulations Questions and Answers (PDF - 2 MB)
Final
3/2/1998
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory (PDF - 19 KB)
Final
4/5/2001
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24) (PDF - 3 MB)
Draft released for comment
Draft
8/29/2006
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 (PDF - 4 MB)
Final
Posted
3/2/1998
Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF - 98 KB)
Final
10/11/2006
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150 KB)
Draft
4/17/1998
Marketed Unapproved Drugs—Compliance Policy Guide (PDF - 66 KB)
Final
6/8/2006
Monitoring of Clinical Investigations (PDF - 433 KB)
Final
Posted
3/2/1998
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (PDF - 3 MB)
Final
Posted
3/2/1998
Part 11, Electronic Records; Electronic Signatures—Scope and Application (PDF - 215 KB)
Final
9/3/2003
PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315 KB)
Final
9/29/2004
PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399 KB)
Final
9/15/2005
Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137 KB)
Final
8/6/2009
Pharmacy Compounding—Compliance Policy Guide (PDF - 793 KB)
Final
5/2002
Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8 KB)
Final
8/23/1999
Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment (PDF - 297 KB)
Draft
11/2003
• Revised Attachments (PDF - 159 KB)
Preparation of Investigational New Drug Products (Human and Animal)(PDF - 795 KB)
Final
11/1992
Prescription Drug Marketing Act—Donation of Prescription Drug Samples to Free Clinics (PDF - 38 KB)
Final
3/2006
• Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF - 112 KB) (Issued and Posted 11/13/2006)
Process Validation: General Principles and Practices (PDF - 194 KB)
Draft
11/17/2008
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 443 KB)
Final
9/27/2006
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs(updated 6/29/2009
Final
8/4/2004
Review of FDA's Implementation of the Drug Export Amendments of 1986 (PDF - 2 MB)
Final
11/1989
Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice (PDF - 734 KB)
Final
9/29/2004
Street Drug Alternatives (PDF - 11 KB)
Final
3/2000
Testing of Glycerin for Diethylene Glycol (PDF - 36 KB)
Final
5/1/2007
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2—Current Good Manufacturing Practice (CGMP)(PDF - 38 KB)
Final
1/26/2010
Drug Safety
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF - 1516 KB)
Final
2/2005
Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206 KB)
Final
7/29/2009
Drug Safety Information - FDA's Communication to the Public (PDF - 114 KB)
Final
3/2/2007
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (PDF - 316 KB)
Draft
9/30/2009
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (PDF - 173 KB)
Draft
7/15/2009
Electronic Submissions
Indexing Structured Product Labeling (PDF - 59 KB)
Final
6/2/2008
Part 11, Electronic Records; Electronic Signatures—Scope and Application (PDF - 215 KB)
Final
9/3/2003
Providing Regulatory Submissions in Electronic Format—ANDAs
Withdrawn FR Notice 10/5/2006
Final
Withdrawn
FR Notice
6/2002
Providing Regulatory Submissions in Electronic Format -Annual Reports for NDAs and ANDAs
Withdrawn FR Notice 10/5/2006
Draft
Withdrawn
FR Notice
Posted
8/27/2003
Providing Regulatory Submissions in Electronic Format—Content of Labeling (PDF - 28 KB)
Final
4/20/2005
Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing (PDF - 123 KB)
Final
5/28/2009
Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications(PDF - 133 KB)
To ensure that you have the most recent versions of the specifications referenced in this document, check the appropriate center's Web page. CBER Topics page. CDER Topics page.
Final
Revised
06/11/2008
Providing Regulatory Submissions in Electronic Format -General Considerations (PDF - 288 KB) (Issued, Posted 10/22/2003)
Draft
10/2003
Providing Regulatory Submissions in Electronic Format-Postmarketing Individual Case Safety Reports (PDF - 107 KB)
To ensure that you have the most recent versions of the specifications referenced in this document, check the appropriate center's Web page. CBER Topics page. CDER Topics page.
Draft
6/11/2008
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling (PDF - 28 KB)
Draft
1/2001
Providing Regulatory Submissions in Electronic Format—Receipt Date (PDF - 59 KB)
Draft
6/4/2007
Regulatory Submissions in Electronic Format; General Considerations (PDF - 54 KB)
Final
1/1999
Regulatory Submissions in Electronic Format; New Drug Applications
Withdrawn FR Notice 10/5/2006
Final
Withdrawn
FR Notice
1/1999
SPL Standard for Content of Labeling Technical Qs & As (PDF - 58 KB)
Draft
10/2009
FDAAA (Food and Drug Administration Amendments Act)
Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 4020) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 (PDF - 314 KB)
Draft
4/2008
Generics
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (PDF - 162 KB)
Final
7/2003
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (PDF - 14 KB)
Final
12/2000
ANDAs: Impurities in Drug Products (PDF - 104 KB)
Draft
8/26/2005
ANDAs: Impurities in Drug Substances (PDF - 136 KB)
Final
7/15/2009
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information (PDF - 125 KB)
Final
7/6/2007
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF - 25 KB)
Final
3/2000
Handling and Retention of Bioavailability and Bioequivalence Testing Samples (PDF - 166 KB)
Final
5/25/2004
Individual Product Bioequivalence Recommendations (PDF - 45 KB)
List of Product Bioequivalence Recommendations
Draft
5/30/2007
Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past. (PDF - 194 KB)
Final
8/1995
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 (PDF - 274 KB)
Final
10/1994
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 (PDF - 1915 KB)
Final
4/1994
Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (PDF - 254 KB)
Final
7/1992
Letter on the provision of new procedures and policies affecting the generic drug review process (PDF - 608 KB)
Final
3/1989
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 (PDF - 917 KB)
Final
11/1990
Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act(PDF - 392 KB)
Final
3/1985
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 (PDF - 233 KB)
Final
1/1993
Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (PDF - 908 KB)
Final
8/1993
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 (PDF - 57 KB)
Draft
10/2004
Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (PDF - 24 KB)
Final
12/2001
Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (PDF - 48 KB)
Final
10/25/2005
Revising ANDA Labeling Following Revision of the RLD Labeling (PDF - 19 KB)
Final
4/26/2000
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (PDF - 183 KB)
Draft
4/16/2009
Variations in Drug Products that May Be Included in a Single ANDA (PDF - 107 KB)
Final
12/1998
Good Review Practices
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF - 1516 KB)
Final
2/2005
Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff : Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007
Final
1/21/2009
Pharmacology/Toxicology Review Format (PDF - 55 KB)
Final
5/2001
International Conference on Harmonisation - Efficacy
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (PDF - 17 KB)
Final
3/1995
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 49 KB)
Final
3/1995
E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports (PDF - 69 KB)
Final
1/15/1998
• E2BM Data Elements for Transmission Of Individual Case Safety Reports (PDF - 74 KB) (Issued 4/2002, Posted 4/4/2002)
○ E2B(M) Questions and Answers (PDF - 55 KB) (Revised 3/09/2005, Posted, 3/16/2005)
E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (PDF - 269 KB) (Issued , Posted 9/30/2005)
Draft
9/30/2005
E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
Note: In November 2005, the ICH incorporated the E2C addendum with the E2C parent guidance and retitled the combined document E2C(R1). The contents of the two guidances were not revised.
• E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (PDF - 169 KB)
Final
5/19/1997
• E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (PDF - 35 KB)
Final
2/5/2004
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 184 KB)
Draft
9/12/2003
E2E Pharmacovigilance Planning (PDF - 73 KB)
Final
3/31/05
E2F Development Safety Update Report (PDF - 118 KB)
Draft
8/4/2008
E3 Structure and Content of Clinical Study Reports (PDF - 240 KB)
Final
7/1996
E4 Dose-Response Information to Support Drug Registration (PDF - 49 KB)
Final
7/1996
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data
• E5 Questions and Answers (PDF - 48 KB) [Issued 9/27/2006; Posted 9/28/2006]
Final
6/2004
E6 Good Clinical Practice: Consolidated Guideline (PDF - 262 KB)
Spanish Version (PDF - 151 kb)
Final
5/9/1997
E7 Studies in Support of Special Populations: Geriatrics (PDF - 25 KB)
Final
8/1994
E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers (PDF - 125 KB)
Draft
11/9/2009
E8 General Considerations for Clinical Trials (PDF - 67 KB)
Final
12/1997
E9 Statistical Principles for Clinical Trials (PDF - 110 KB)
Final
9/1/1998
E10 Choice of Control Group and Related Issues in Clinical Trials (PDF - 93 KB)
Final
5/2001
E11 Clinical Investigation of Medicinal Products in the Pediatric Population (PDF - 60 KB)
Final
12/2000
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs. (PDF - 27 KB)
Draft
8/2000
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF - 67 KB)
Final
10/19/2005
Questions and Answers (PDF - 108 KB)
11/18/2008
E15 Pharmacogenomics Definitions and Sample Coding (PDF - 90 KB)
Final
4/7/2008
E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions (PDF - 135 KB)
Draft
7/30/2009
International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)
M2 eCTD: Electronic Common Technical Document Specification (PDF - 1,020 KB)
Final
4/1/2003
• M2: eCTD Specification Questions and Answers and Change Requests (PDF 17 KB)
3/14/05
• Companion Document: Current Q & As and Change Requests
7/10/2008
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (PDF - 295 KB)
Final
1/20/2010
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use
Final
Originally
Issued
10/15/2001
• M4: Organization of the CTD (PDF - 31 KB)
• M4 Granularity Annex (PDF - 124 KB) (Issued 10/18/2005, Posted 10/18/2005)
• M4: The CTD—General Questions and Answers (PDF - 29 KB) (Issued 12/04, Posted 12/22/2004)
• M4: The CTD—Quality (PDF - 79 KB)
• M4: The CTD—Quality Questions and Answers /Location Issues (PDF - 49 KB) (Issued 6/2004, Posted 6/8/2004)
• M4: The CTD—Efficacy (PDF - 156 KB)
• M4: The CTD—Efficacy Questions and Answers (PDF - 34 KB) (Issued 12/2004, Posted 12/22/2004)
Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format [esrs/eCTD page].
• M4: The CTD—Safety (PDF - 60 KB)
• M4: The CTD—Safety Appendices (PDF - 178 KB)
○ M4: The CTD—Safety Questions and Answers (PDF - 16 KB) (Issued 2/2003, Posted 2/4/2003)
M5 International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries (PDF - 288 KB)
Draft
9/2005
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF - 50 KB)
Draft
9/2001
International Conference on Harmonisation - Quality
Q1A(R2) Stability Testing of New Drug Substances and Products (PDF - 58 KB)
Final
11/2003
Q1B Photostability Testing of New Drug Substances and Products (PDF - 339 KB)
Final
11/1996
Q1C Stability Testing for New Dosage Forms (PDF - 101 KB)
Final
5/9/1997
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (PDF - 31 KB)
Final
1/2003
Q1E Evaluation of Stability Data (PDF - 221 KB)
Final
6/2004
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV, revision 1
Final
Withdrawn
7/6/2006
Q2(R1) Validation of Analytical Procedures: Text and Methodology
Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined Q2 document. The contents of the two guidances were not revised.
• Q2A Text on Validation of Analytical Procedures (PDF - 25 KB)
Final
3/1995
• Q2B Validation of Analytical Procedures: Methodology (PDF - 132 KB)
Final
5/19/1997
Q3A(R) Impurities in New Drug Substances (PDF - 55 KB)
Final
6/6/2008
Q3B(R) Impurities in New Drug Products (Revision 2)(PDF - 171 KB)
Final
8/4/2006
Q3C Impurities: Residual Solvents (PDF - 41 KB)
Final
12/24/1997
Q3C Tables and List (PDF - 33 KB)
Final
11/12/2003
• Appendix 4 (PDF - 120 KB); Appendix 5 (PDF - 216 KB); Appendix 6 (PDF - 128 KB) (Appendices were issued with the Q3C draft guidance documents)
Maintenance Procedures for Updating
Final
2/11/2002
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (PDF - 55 KB)
Final
2/20/2007
• Annex I: Residue on Ignition/Sulphated Ash General Chapter (PDF - 36 KB)
Final
2/20/2007
• Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 79 KB)
Final
1/8/2009
• Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter (PDF - 1208 KB)
Final
1/8/2009
• Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF - 81 KB)
Final
4/7/2009
• Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF - 82 KB)
• Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF - 75 KB)
• Annex 5: Disintegration Test General Chapter (PDF - 32 KB)
Final
12/22/2009
• Annex 6:Uniformity of Dosage Units General Chapter (PDF - 87 KB)
Final
4/2/2010
• Annex 7:Dissolution Test General Chapter (PDF - 93 KB)
• Annex 8: Sterility Test General Chapter (PDF - 32 KB)
Final
12/22/2009
• Annex 9: Tablet Friability General Chapter (PDF - 84 KB)
Final
4/2/2010
• Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 84 KB)
Final
4/9/2010
• Annex 11: Capillary Electrophoresis General Chapter (PDF - 90 KB)
• Annex 12: Analytical Sieving General Chapter (PDF - 313 KB)
Draft
12/16/2009
Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (PDF - 71 KB)
Final
Posted
9/1998
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products (PDF - 109 KB)
Final
2/1996
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (PDF - 70 KB)
Final
7/1996
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (PDF - 52 KB)34 (Issued , Posted 9/21/1998)
Final
9/21/1998
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (PDF - 58 KB)
Final
6/2005
Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.
Final
12/29/2000
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (PDF - 64 KB)
Final
8/1999
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (PDF - 175 KB)
Note: In November 2005, the ICH redesignated this guidance. Q7 The guidance was not revised.
Final
8/2001
Q8(R2) Pharmaceutical Development (PDF - 402 KB)
Final
11/20/2009
Q9 Quality Risk Management (PDF - 113 KB)
Final
6/1/2006
Q10 Pharmaceutical Quality System (PDF - 274 KB)
Final
4/7/2009
International Conference on Harmonisation - Safety
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (PDF - 100 KB)
Final
3/1996
S1B Testing for Carcinogenicity of Pharmaceuticals (PDF - 145 KB)
Final
2/28/1998
S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF - 185 KB)
Final
9/17/2008
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (PDF - 123 KB)
Final
4/1996
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (PDF - 131 KB)
Final
11/21/1997
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use(PDF - 242 KB)
Draft
3/24/2008
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF - 46 KB)
Final
3/1995
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF - 14 KB)
Final
3/1995
S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)(PDF - 21 KB)
Final
Posted
6/25/99
S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility
Note: In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised.
• S5A Detection of Toxicity to Reproduction for Medicinal Products (PDF - 87 KB)
Final
9/1994
• S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility (PDF - 98 KB)
Final
4/1996
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF - 137 KB)
Final
11/1997
• Addendum to ICH S6:(PDF - 160 KB)
Preclinical Safety Evaluation of Biotechnology -Derived Pharmaceuticals S6(R1)
Draft
12/16/2009
S7A Safety Pharmacology Studies for Human Pharmaceuticals (PDF - 44 KB)
Final
7/2001
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (PDF - 52 KB)
Final
10/19/2005
S8 Immunotoxicity Studies for Human Pharmaceuticals (PDF - 72 KB)
Final
4/12/2006
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 170 KB)
Final
3/5/2010
Investigational New Drug Applications
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42 KB)
Final
11/1995
• Questions and Answers: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (PDF - 14 KB) (10/2000)
Exploratory IND Studies (PDF - 220 KB)
Final
1/12/2006
Labeling
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 52 KB)
Final
1/18/2006
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 144 KB)
Draft
3/3/2009
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format(PDF - 127 KB)
Final
1/18/2006
Content and Format for Geriatric Labeling (PDF - 38 KB)
Final
10/2001
Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306 KB)
Final
2/5/2010
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (PDF - 143 KB)
Final
3/22/2010
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF - 53 KB)
Draft
3/12/2008
Labeling for Combined Oral Contraceptives (PDF - 92 KB)
Draft
3/2/2004
Labeling for Human Prescription Drugs—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 66 KB)
Final
10/16/2009
Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements (PDF - 213 KB)
Draft
1/18/2006
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) (PDF - 71 KB)
Draft
6/1998
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 (PDF - 458 KB)
Draft
11/15/2005
Public Availability of Labeling Changes in “Changes Being Effected” Supplements (PDF - 26 KB)
Draft
9/19/2006
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (PDF - 32 KB)
Draft
10/26/2000
Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (PDF - 188 KB)
Final
6/26/2009
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 58 KB)
Draft
1/18/2006
Microbiology
Format and Content of the Microbiology Section of an Application* (PDF - 546 KB)
Final
1990
Modernization Act
Changes to an Approved NDA or ANDA (PDF - 108 KB)
Final
4/2004
Classifying Resubmissions in Response to Action Letters (PDF - 76 KB)
Final
5/14/1998
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act
Final
Withdrawn
9/2008
Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 311 KB) (Posted 7/22/2004)
Appendix 2 [(PDF - 3930 KB)] [Appendices are scanned copies, which will be replaced by final versions]
Final
11/17/1998
Formal Dispute Resolution: Appeals Above the Division Level(PDF - 30 KB)
Final
2/2000
Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 89 KB)
Final
5/19/2009
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF - 62 KB)
Final
10/1998
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979 KB)
Final
7/1998
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions(PDF - 34 KB)
Final
3/2002
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 40 KB)
Draft
1/2004
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (PDF - 74 KB)
Final
4/1998
PET Drug Applications - Content and Format for NDAs and ANDAs (PDF - 153 KB)
Draft
3/7/2000
• Sample formats for chemistry, manufacturing, and controls sections (PDF - 125 KB)
• Sample formats for labeling (PDF - 94 KB)
• Sample formats for Form FDA 356h (PDF - 51 KB)
• Sample formats for user fee Form FDA 3397(PDF - 42 KB)
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129 KB)
Final
5/14/1998
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 57 KB)
Final
9/1999
• 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 (PDF - 85 KB)
Final
Revised
5/1998
Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456 KB)
Final
2/15/2006
Standards for Prompt Review of Efficacy Supplements (PDF - 76 KB)
Final
5/15/1998
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43 KB)
Final
8/1998
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26 KB)
Final
10/2000
Over-the-Counter
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)(PDF - 294 KB)
Final
5/1984
General Guidelines for OTC Combination Products (PDF - 270 KB)
Final
11/1978
Label Comprehension Studies for Nonprescription Drug Products (PDF - 204 KB)
Draft
4/30/2009
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) (PDF - 71 KB)
Draft
6/1998
Labeling OTC Human Drug Products—Questions and Answers (PDF - 599 KB)
Final
1/2/2009
Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals (PDF - 34 KB)
Draft
12/2000
Labeling OTC Human Drug Products; Small Entity Compliance Guide (PDF - 270 KB)
Final
5/12/2009
Labeling OTC Human Drug Products Updating Labeling in ANDAs (PDF - 32 KB)
Draft
2/21/2001
• Additional examples 1 (PDF - 32 KB) (3/19/2001)
• Additional examples 2 (PDF - 15 KB) (3/26/2001)
• Additional examples 3 (PDF - 17 KB) (3/26/2001)
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (PDF - 30 KB)
Example Drug Facts Labels
Final
10/2002
• Acetaminophen 120 mg in a Suppository Dosage Form (PDF - 13 KB)
• Acetaminophen 325 mg in a Suppository Dosage Form (PDF - 14 KB)
• Acetaminophen 650 mg in a Suppository Dosage Form (PDF - 14 KB)
• Cimetidine 200 mg in a Tablet Dosage Form (PDF - 13 KB)
• Clemastine Fumerate 1.34 mg in a Tablet Dosage Form(PDF - 14 KB)
• Doxylamine Succinate 25 mg Tablet Dosage Form (PDF - 12 KB)
• Ibuprofen 200 mg in a Tablet/Capsule Dosage Form (PDF - 14 KB)
• Loperamide HCl in a Liquid Dosage Form (PDF - 15 KB)
• Loperamide HCl in a Tablet/Caplet Dosage Form (PDF - 15 KB)
• Miconazole Nitrate Vaginal Products (PDF - 16 KB)
• Minoxidil Topical Solution 2% for Men and Women (PDF - 14 KB)
• Minoxidil Topical Solution 5% for Men (PDF - 17 KB)
• Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form (PDF - 14 KB)
• Pseudoephedrine HCl Extended-Release Tablets 120 mg (PDF - 15 KB)
Labeling OTC Human Drug Products Using a Column Format (PDF - 57 KB)
Final
12/2000
Labeling OTC Skin Protectant Drug Products (PDF - 274 KB)
Draft
Removed
3/18/2010
Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (PDF - 298 KB)
Final
7/13/2009
Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers (PDF - 83 KB)
Final
8/31/2009
Time and Extent Applications (PDF - 46 KB)
Draft
2/2004
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) (PDF - 583 KB)
Final
10/1978
Pharmacology/Toxicology
Animal Models—Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135 KB)
Draft
1/16/2009
Carcinogenicity Study Protocol Submissions (PDF - 29 KB)
Final
5/22/2002
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42 KB)
Final
11/1995
• Questions and Answers: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (PDF - 14 KB) (10/2000)
Developing Medical Imaging Drug and Biological Products
Final
6/17/2004
• Part 1: Conducting Safety Assessments (PDF - 271 KB)
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (PDF - 702 KB)
Final
7/21/2005
Exploratory IND Studies (PDF - 220 KB)
Final
1/12/2006
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (PDF -1300 KB)
Final
2/1987
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (PDF - 169 KB)
Draft
12/15/2008
Immunotoxicology Evaluation of Investigational New Drugs (PDF - 100 KB)
Final
10/2002
Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (PDF - 142 KB) (Issued , Posted 11/9/2001)
Draft
11/2001
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (PDF - 233 KB)
Draft
6/17/2005
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
Final
10/96
Updated
7/2005
Nonclinical Safety Evaluation of Drug or Biologic Combinations (PDF - 100 KB)
Final
3/14/2006
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (PDF - 76 KB)
Draft
3/7/2008
Nonclinical Safety Evaluation of Pediatric Drug Products (PDF - 479 KB)
Final
2/14/2006
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients(PDF - 230 KB)
Final
05/18/2005
Photosafety Testing (PDF - 179 KB)
Final
5/7/2003
Recommended Approaches to Integration of Genetic Toxicology Study Results (PDF - 190 KB)
Final
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 (PDF - 837 KB)
Final
3/2/1998
Safety Testing of Drug Metabolites (PDF - 86 KB)
Final
2/14/2008
Single Dose Acute Toxicity Testing for Pharmaceuticals (PDF - 63 KB)
Final
8/1996
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (PDF - 135 KB)
Draft
5/2001
Procedural
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF - 77 KB)
Final
6/1998
Applications Covered by Section 505(b)(2)(PDF - 41 KB)
Draft
10/1999
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 164 KB)
Draft
1/16/2009
Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administation
Draft
12/2006
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (PDF - 64 KB)
Final
2/22/2008
Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under PDUFA (PDF - 195 KB)
Final
Withdrawn
4/9/2010
Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA (PDF - 168 KB)
Final
Withdrawn
4/9/2010
• Paperwork Reduction Act Burden Statement (PDF - 72 KB) (Posted 7/27/2004)
Cooperative Manufacturing Arrangements for Licensed Biologics
Final
12/3/2008
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF - 25 KB)
Final
Posted
3/27/2000
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 (PDF - 30 KB)
Draft
12/1999
Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees
Draft
2/14/2002
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 (PDF - 10 KB)
Final
11/1999
Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate—Labeling Enforcement Policy (PDF - 159 KB)
Final
6/3/2003
Emergency Use Authorization of Medical Products; Availability (PDF - 4070 KB)
Draft
7/5/2005
End-of-Phase 2A Meetings (PDF - 163 KB)
Final
9/18/2009
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act
Withdrawn
9/2008
Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83 KB)
Appendix 2 (PDF - 3930 KB)15 [Appendices are scanned copies, which will be replaced by final versions] (Issued 11/17/1998, Posted 11/17/1998)
Final
1/12/2006
FDA Export Certificates
Final
7/2004
Financial Disclosure by Clinical Investigators
Final
3/27/2001
Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV (PDF - 343 KB)
Final
10/17/2006
Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30 KB)
Final
2/2000
Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89 KB)
Final
5/19/2009
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF - 32 KB)
Draft
5/14/2001
Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S.
Final
1/14/2009
Good Review Management Principles and Practices for PDUFA Products (PDF - 683 KB)
Final
3/2005
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations (PDF - 143 KB)
Final
Revised
6/2003
Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs—Improving Human Subject Protection (PDF - 61 KB)
Final
1/14/2009
Guidance to Pharmacies: Compounding Tamiflu Oral Suspension in Advance to Provide for Multiple Prescriptions (PDF - 114KB)
Draft
1/11/2010
Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials (PDF - 399 KB)
Draft
12/2/2008
How to Comply with the Pediatric Research Equity Act (PDF - 116 KB)
Draft
9/7/2005
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF - 62 KB)
Final
10/1998
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979 KB)
Final
7/1998
Independent Consultants for Biotechnology Clinical Trial Protocols
Final
8/18/2004
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 40 KB) [Revision 1]
Draft
1/2004
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 34 KB)
Final
3/2002
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF - 27 KB)
Final
11/2001
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions - Statement of Investigator (Form FDA 1572) (PDF - 672 KB)
Draft
7/29/2008
Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF - 98 KB)
Final
4/20/2009
Integrated Summary of Effectiveness (PDF - 95 KB)
Draft
7/26/2008
Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163 KB)
Final
10/23/2009
Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (PDF - 24 KB)
Final
7/2001
Medication Guides—Adding a Toll-Free Number for Reporting Adverse Events (PDF - 67 KB)
Final
6/8/2009
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (PDF - 74 KB)
Final
4/1998
PET Drug Applications - Content and Format for NDAs and ANDAs (PDF - 153 KB) [(Issued , Posted 3/7/2000)
Draft
3/7/2000
• Sample formats for chemistry, manufacturing, and controls sections (PDF - 125 KB)
• Sample formats for labeling (PDF - 94 KB)
• Sample formats for Form FDA 356h (PDF - 51 KB)
• Sample formats for user fee Form FDA 3397 (PDF - 41 KB)
Pharmacogenomic Data Submissions (PDF - 96 KB)
• Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (PDF - 63 KB)
Final
3/2005
Pharmacogenomic Data Submissions—Companion Guidance (PDF - 211 KB)
Draft
8/28/2007
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 47KB)
Draft
1/7/2010
Postmarketing Adverse Even Reporting for Medical products and Dietary Supplements During an Influenza Pandemic (PDF - 246 KB)
Draft
12/15/2008
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF - 375 KB)
Draft
3/9/2001
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (PDF - 40 KB)
Final
12/10/2001
• KI in Radiation Emergencies-Questions and Answers (PDF - 161 KB)
12/23/2002
Potassium Iodide Tablets - Shelf Life Extension (PDF - 156 KB)
Final
3/8/2004
Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees (PDF - 68 KB)
Draft
3/21/2007
Process for Handling Referrals to FDA Under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations (PDF - 116 KB) [PDF]
Final
12/22/2006
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 57 KB)
Final
9/1999
Refusal to File (PDF - 304KB)
Final
7/12/1993
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (PDF - 85 KB)
Final
Revised
5/1998
Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456 KB)
Final
2/15/2006
Special Protocol Assessment (PDF - 36 KB)
Final
5/2002
Standards for Prompt Review of Efficacy Supplements (PDF - 76 KB)
Final
5/15/1998
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
Final
3/26/2010
Submission of Patent Information for Certain Old Antibiotics (PDF - 42 KB)
Draft
11/28/2008
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)(PDF - 26 KB)
Final
10/2000
Submitting Debarment Certification Statements (PDF - 144 KB)
Draft
10/2/98
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF - 50 KB)
Draft
9/5/2001
Target Product Profile—A Strategic Development Process Tool (PDF - 454 KB)
Draft
3/29/2007
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products (PDF - 112 KB)
Draft
6/2/2009
The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 33 KB)
Draft
4/2002
Tropical Disease Priority Review Vouchers (PDF - 112 KB)
Draft
10/21/2008
Useful Written Consumer Medication Information (CMI)(PDF - 73 KB)
Final
7/17/2006
Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87 KB)
Final
3/15/2006
Waiver of IRB Requirements for Drug and Biological Product Studies (PDF - 35 KB)
Final
1/2006
Women and Minorities Guidance Requirements (PDF - 30 KB)
Final
7/20/1998
Small Entity Compliance Guides
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation—Small Entity Compliance Guide (PDF - 18 KB)
Final
11/7/2001
Labeling OTC Human Drug Products (Small Entity Compliance Guide)(PDF - 481 KB)
Draft
12/2004
User Fees
Attachment G—Draft Interim Guidance Document for Waivers of and Reductions in User Fees (PDF - 897 KB)
Draft
7/16/1993
Classifying Resubmissions in Response to Action Letters (PDF - 76 KB)
Final
5/14/1998
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (PDF - 48 KB)
Final
6/1999
Guidance for Industry and FDA Staff: Application User Fees for Combination Products (PDF - 83 KB)
Final
4/2005
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF - 27 KB)
Final
11/2001
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211 KB)
Final
12/30/2004
User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (PDF - 46 KB) (Issued , Posted 2/7/2007)
Final
2/7/2007
IV. Center for Devices and Radiological Health (CDRH)
For information a specific guidance document or to obtain a paper copy, contact:
Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993, 1-800-638-2041, FAX: 301-847-2149, e-mail:
dsmica@fda.hhs.gov
,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/Default.htm
.
CDRH has no withdrawn guidance documents at this time.
The following list of current CDRH guidance documents was obtained from FDA's Web site on April 22, 2010:
Title
Organization
Doc #
Date
Cross-Center Guidance Document List
Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
CBER CDRH
1511
08/27/09
Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria
CBER CDRH
1200
08/06/09
Presenting Risk Information in Prescription Drug and Medical Device Promotion
User Fees and Refunds for Premarket Approval Applications
CBER CDRH
1681
03/13/09
Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
CBER CDRH
1532
03/02/09
Assay Migration Studies for In Vitro Diagnostic Devices
CBER CDRH/OIVD
1660
01/05/09
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
CBER CDRH/ODE
1615
12/12/08
Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision
CBER CDRH
1584
12/11/08
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
CBER CDRH
1668
08/05/08
FY 2009 Medical Device User Fee Small Business Qualification and Certification (PDF only)
CBER CDRH
08/01/08
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
CBER CDRH
1218
06/30/08
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
CBER CDRH
108
02/29/08
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
CBER CDRH
1655
02/28/08
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
CBER CDRH
1215
06/22/07
Guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers
CBER CDER CDRH
1549
02/09/06
Annual Reports for Approved Premarket Approval Applications (PMA)
CBER CDRH
1585
10/26/06
Real-Time Premarket Approval Application (PMA) Supplements
CBER CDRH
673
04/28/06
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
CBER CDRH
1588
04/25/06
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
CBER CDRH/ODE CDRH/OIVD
337
05/11/05
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
CBER CDRH
4444
11/30/04
Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA
CBER CDRH
1303
11/17/04
Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
CBER CDRH
1511
08/27/09
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
CBER CDRH
1219
05/21/04
Premarket Assessment of Pediatric Medical Devices
CBER CDRH
1220
05/14/04
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
CBER CDRH
1224
11/24/03
Premarket Approval Application Modular Review
CBER CDRH/ODE
835
11/03/03
Premarket Approval Application Filing Review
CBER CDRH/ODE CDRH/OIVD
297
05/01/03
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
CBER CDRH
1201
02/25/03
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
CBER CDRH/ODE
1332
10/04/02
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
CBER CDRH/OC
938
01/11/02
OC Guidance Documents
Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007
OC/DRMO/RPSB
1657
10/08/09
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
OC/DE2/OBGUB
1688
12/23/08
Medical Device Tracking; Guidance for Industry and FDA Staff
OC
169
01/25/10
Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves
OC/DE2
1141
07/11/08
Surveillance and Detention Without Physical Examination of Condoms
OC/DE2
1139
07/11/08
The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations
OIVD OC
1566
01/08/08
The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
OC/DBM
1602
01/08/08
Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
OC
1227
02/27/07
Decorative, Non-corrective Contact Lenses
OC/DE1
1613
11/24/06
Inspection of Medical Device Manufacturers
OC/DPO/FPB
06/15/06
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
OC
1217
05/01/06
Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex
OC/DE2/OBGUB
1548
11/14/05
Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators
ODE OC
1304
10/06/05
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
ODE OC
1553
01/14/05
Consumer-Directed Broadcast Advertising of Restricted Devices
OC
1513
02/10/04
User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide
OC
1212
04/01/03
Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
OC/DE3
1140
02/03/03
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
CBER CDRH/OC
938
01/11/02
Sterilized Convenience Kits for Clinical and Surgical Use
OC
1390
01/07/02
Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA
OC/DE3
1392
07/30/01
Implementation of the Biomaterials Access Assurance Act of 1998
OC
1324
04/02/01
Labeling for Electronic Anti-Theft Systems
OC/DE3
1170
08/15/00
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals
OC/DE3
1168
08/14/00
Alternative to Certain Prescription Device Labeling Requirements
OC
1150
01/21/00
Regulating In Vitro Diagnostic Device (IVD) Studies
OC/DBM
1132
12/17/99
Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables (PDF version)
OC/DE1
1129
11/15/99
Guidance for FDA Staff: Civil Money Penalty Policy
OC
1124
06/08/99
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects
OC/DBM
2229
03/19/99
Performance Standard for Electrode Lead Wires and Patient Cables
OC
1197
03/16/98
Information about Lasers: An Important Letter to Ophthalmologists About Lasers for Refractive Surgery
OC/DE2
8323
06/27/97
Design Control Guidance For Medical Device Manufacturers
OC/DE3
994
03/11/97
Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection
OC/DE2
1394
10/31/96
Electromagnetic Compatibility - A Letter to Industry
OC/DE3
1087
09/18/96
Shielded Trocars and Needles used for Abdominal Access during Laparoscopy (PDF Version)
OC/DE2
1122
08/23/96
Letter to Manufacturers and Initial Distributors of Hemodialyzers (PDF only)
OC/DE2
2507
05/23/96
Reuse of Medical Disposable Devices Policy
OC/DE3
961
12/27/95
Letter to Medical Device Manufacturer on Pentium processors (PDF only)
OC
456
02/14/95
Medical Devices and EMI: The FDA Perspective
OC/DE3
1082
01/01/95
Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims (PDF only)
OC/DE2
851
06/30/94
All Device Manufacturers/Repackers Using Cotton (PDF Version)
OC/DE2
101
04/22/94
Letter - Condom Manufacturers and Distributors (PDF only)
OC/DE2
56
04/05/94
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) (PDF only)
OC/DE2
52
02/23/94
Manufacturers And Initial Distributors Of Sharps Containers And Destroyers Used By Health Care Professionals (PDF Version)
OC/DE2
933
02/03/94
Endoscopy and Laparoscopy Accessories (PDF only)
OC/DE1
545
05/17/93
Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson (PDF Only)
OC/DE2
869
05/10/93
Latex Labeling Letter (Johnson) (PDF only)
OC/DE2
831
03/18/98
Dental Handpiece Sterilization (Dear Doctor Letter) (PDF only)
OC/DE2
589
09/28/92
Computerized Devices/Processes Guidance (PDF Version)
OC/DE3
247
05/01/92
Commercial Distribution/Exhibit Letter (PDF only)
OC
246
04/10/92
Quality Assurance Guidelines for Hemodialysis Devices
OC/DE3
507
02/01/91
Letter - Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) (PDF only)
OC/DE2
53
02/13/89
Color Additive Status List (PDF Only)
OC
268
02/01/89
Color Additive Petitions (PDF Only)
OC
296
06/01/87
Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/8/87) (PDF only)
OC/DE2
293
04/08/87
All U.S. Condom Manufacturers, Importers and Repackagers (PDF only)
OC/DE2
2510
04/07/87
Standard Specification for Rubber Contraceptives (Condoms) (PDF Only)
OC/DE2
628
10/28/83
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure (PDF only)
OC/DE2
1019
06/23/78
Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations (PDF Version)
OC/DE3
1086
Office of the Center Director Guidance Documents
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
07/02/01
OCER Guidance Documents
Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals
OCER/DMQRP/EPB
03/18/10
Draft Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13
OCER/DMQRP
1695
10/09/09
Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use
OCER/DMQRP
1680
12/24/08
Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment
OCER/DMQRP/RPB
05/15/08
Medical Glove Guidance Manual
OCER/DSMICA
1661
01/22/08
Inspection and Field Testing of Radiation-Emitting Electronic Products
OCER/DMQRP
10/31/07
Impact-Resistant Lenses: Questions and Answers
OCER/DSMICA
23
10/26/07
Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)
OCER/DMQRP
1639
09/25/07
Compliance Guide for Cabinet X-Ray Systems
OCER/DMQRP
1634
09/19/07
Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs)
OCER/DHC
1645
07/19/07
Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50)
OCER/DMQRP
1346
06/24/07
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide
OCER/DMQRP
1640
06/07/07
Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device
05/01/07
Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)
OCER/DMQRP
1633
03/23/07
The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12
OCER/DMQRP
1623
02/02/07
Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes
OCER/DMQRP
1612
10/20/06
Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens
OCER/DMQRP
1611
10/20/06
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
OCER/DMQRP
1609
10/20/06
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment
OSB/DPS OCER/DHC
1537
03/10/06
Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) X-ray Equipment - Guidance for FDA Staff
OCER/DMQRP
1600
02/08/06
Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54)
OCER/DMQRP OCER/DMQRP/EPDB
1592
01/06/06
Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)
OCER/DMQRP/EPDB
1565
11/06/05
Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA
OCER/DMQRP/ICB
6409
09/13/05
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems
OCER/DMQRP/DDB
2619
09/05/03
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions
OCER/DHC
1427
07/16/03
Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products (Laser Notice No. 52)
OCER/DMQRP
1412
07/12/02
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/DHC
1408
07/09/02
Compliance Guidance: The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final
OCER/DMQRP/ICB
6400
11/05/01
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/DHC
1333
07/06/01
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)
OCER/DMQRP/EPDB
1349
05/27/01
Guidance on Medical Device Patient Labeling
OCER/DHC
1128
04/19/01
CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff
OCER/DHC
1323
02/09/01
Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties
OCER/DSMICA
1160
02/02/01
Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations
1173
09/27/00
Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
OCER/DHC
1497
07/18/00
Regulation of Medical Devices: Background Information for International Officials
OCER/DSMICA
610
04/14/99
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies (PDF Only)
OCER/DMQRP
1071
08/13/98
Overview of FDA Modernization Act of 1997, Medical Device Provisions
OCER/DSMICA
1174
02/19/98
Medical Device Appeals and Complaints: A Guidance on Dispute Resolution (PDF Only)
OCER/DSMICA
396
02/19/98
FDA Modernization Act of 1997 - Guidance for the Device Industry on Implementation of Highest Priority Provisions
OCER
434
02/06/98
Medical Device Reporting for Manufacturers
OCER/DSMICA
987
03/01/97
Human Factors Points to Consider for IDE Devices
OCER/DHC
839
01/17/97
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
OCER/DSMICA
471
01/01/97
Do It By Design - An Introduction to Human Factors in Medical Devices
OCER/DHC
995
12/01/96
Medical Device Quality Systems Manual
OCER/DSMICA
6303
12/01/96
Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49) (PDF only)
OCER/DMQRP
09/05/96
Identification Labels for Certain Class I Laser Products (Laser Notice 48) (PDF Only)
OCER/DMQRP
09/05/96
Effective Visual Control of Laser Projections (Laser Notice 47) (PDF Only)
OCER/DMQRP
06/06/96
Medical Device Reporting for User Facilities (PDF Only)
OCER/DHC
04/01/96
A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use
OCER/DMQRP/DDB
977
03/01/96
A Guide For The Submission Of An Abbreviated Initial Report On X-Ray Tables, Cradles, Film Changers Or Cassette Holders Intended For Diagnostic Use (PDF Only)
OCER/DMQRP/DDB
978
All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) (PDF Only)
OCER/DMQRP
12/11/95
Guide for Preparing Product Reports for Lasers and Products Containing Lasers (PDF Only)
OCER/DMQRP/EPDB
277
09/01/95
Labeling of Laser Products (Laser Notice 45) (PDF Only)
OCER/DMQRP
08/15/95
User Instruction for Medical Products (Laser Notice 44) (PDF Only)
OCER/DMQRP
08/11/95
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 (PDF Only)
OCER/DMQRP/EPDB
236
08/01/95
Certification Statement for the Impact Resistance Test (PDF Only)
OCER/DSMICA
1460
10/25/93
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) (PDF Only)
OCER/DMQRP/DDB
116
10/13/93
Human Factors Principles for Medical Device Labeling (PDF Only)
OCER/DHC
227
09/01/93
Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (PDF Only)
OCER/DMQRP
06/07/93
Compliance Guide for Laser Products (FDA 86-8260) (PDF Only)
OCER/DMQRP/EPDB
278
06/01/92
Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) (PDF Only)
OCER/DMQRP
12/18/89
Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (PDF Only)
OCER/DSMICA
470
09/01/89
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)
OCER/DMQRP
758
03/01/89
Imports Radiation-Producing Electronic Products (FDA 89-8008) (PDF Only)
OCER/DMQRP/EPDB
756
11/01/88
Low Power Laser Reporting Exemption (Laser Notice 40) (PDF Only)
OCER/DMQRP
08/09/88
Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only)
OCER/DMQRP/EPDB
286
03/01/88
Impact Resistant Lenses: Questions and Answers (FDA 87-4002) (PDF Only)
OCER/DSMICA
23
09/01/87
User Instructions - Multi Axis Workstations (Laser Notice 39) (PDF Only)
OCER/DMQRP
06/24/87
Importation for Investigation And Evaluation (Laser Notice 38) (PDF Only)
OCER/DMQRP
05/22/87
Policy on Lamp Compatibility (sunlamps) (PDF Only)
OCER/DMQRP/EPDB
2343
09/02/86
Procedures for Laboratory Compliance Testing of Television Receivers (PDF Only)
OCER/DMQRP/EPDB
945
05/01/86
Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems
OCER/DMQRP/DDB
271
12/01/85
Walk-In Workstations (Laser Notice 37) (PDF Only)
OCER/DMQRP
10/21/85
Low Power Laser Exemption (Laser Notice 36) (PDF Only)
OCER/DMQRP
08/23/85
Policy on Warning Label Required on Sunlamp Products (PDF Only)
OCER/DMQRP/EPDB
1343
06/25/85
User Instruction Hazard Warnings (Laser Notice 35) (PDF Only)
OCER/DMQRP
02/05/85
Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF Only)
OCER/DMQRP
01/20/85
A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components
OCER/DMQRP/DDB
257
01/01/82
Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (PDF Only)
OCER/DMQRP/EPDB
343
09/16/81
Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 (PDF Only)
OCER/DMQRP/EPDB
880
08/24/81
Investigational Medical Laser Significant Risk Device (Laser Notice 31) (PDF Only)
OCER/DMQRP
05/18/81
Laser Diodes Used in Fiber Optics Communication Systems (Laser Notice 27) (PDF Only)
OCER/DMQRP
10/16/80
Alternate Wording For Caution Statement (Laser Notice 30) (PDF Only)
OCER/DMQRP
08/25/80
Guide for the filing of Annual Reports for X-Ray Components and Systems (PDF Only)
OCER/DMQRP/EPDB
253
07/01/80
Open Door Operation of Microwave Ovens as a Result of Oven Miswiring (PDF Only)
OCER/DMQRP/EPDB
646
03/28/80
Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (PDF Only)
OCER/DMQRP
09/14/79
Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (PDF Only)
OCER/DMQRP
11/23/77
Emission Delay - Remote Interlock Connector (Laser Notice 21) (PDF Only)
OCER/DMQRP
11/11/77
Optional Interlocks - Labeling (Laser Notice 17) (PDF Only)
OCER/DMQRP
03/02/77
Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) (PDF Only)
OCER/DMQRP
03/02/77
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF Only)
OCER/DMQRP
12/08/76
Lasers Manufactured and Used In-House (Laser Notice 14) (PDF Only)
OCER/DMQRP
11/23/76
Manufacture and Certification of Laser Kits (Laser Notice 13) (PDF Only)
OCER/DMQRP
10/14/76
Remote Interlock Connectors (Laser Notice 11) (PDF Only)
OCER/DMQRP
10/07/76
Interlock Design (Laser Notice 12) (PDF Only)
OCER/DMQRP
09/09/76
Emission Indicator - Visibility (Laser Notice 10) (PDF Only)
OCER/DMQRP
08/31/76
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (PDF Only)
OCER/DMQRP
08/23/76
Viewing Optics - Sighting Telescope (Laser Notice 8) (PDF Only)
OCER/DMQRP
08/05/76
Components and Repair (Laser Notice 7) (PDF Only)
OCER/DMQRP
06/23/76
Emission Indicators - Brightness (Laser Notice 6) (PDF Only)
OCER/DMQRP
06/22/76
Protective Eyewear - Visibility of Emission Indicator (Laser Notice 4) (PDF Only)
OCER/DMQRP
11/21/75
Emission Indicators on Energy Source (Laser Notice 3) (PDF Only)
OCER/DMQRP
11/21/75
Laser Energy Source (Laser Notice 2) (PDF Only)
OCER/DMQRP
11/21/75
COMPARISON CHART: 1996 QUALITY System Regulation Versus 1978 GOOD Manufacturing Practices Regulation Versus ANSIIISOIASQC Q9001-1994 AND ISO/DIS 13485:1996 (PDF Version)
OCER/DSMICA
ODE Guidance Documents 2010
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications
ODE/DCD/CSPDB
1607
01/20/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief
ODE/DRARD/ULDB
1574
04/05/10
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief In
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