Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal RegisterOct 24, 2001
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under 21 CFR 10.115(n)(2) of FDA's regulation on Good Guidance Practices (GGPs). This list is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.
DATES:
We welcome general comments on this list and on agency guidance documents at any time.
ADDRESSES:
Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov.dockets/ecomments. We have provided information in the tables below on where to obtain a single copy of any of the guidance documents listed.
FOR FURTHER INFORMATION CONTACT:
Carol A. Kimbrough, Office of Policy, Planning, and Legislation (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
We published our final rule on GGPs in the
Federal Register
of September 19, 2000 (65 FR 56468), and they became effective October 19, 2000. GGPs 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. We committed in the GGPs to publishing annually a comprehensive list of guidance documents. This list updates a comprehensive list published July 21, 2000 (65 FR 45428).
The following comprehensive list identifies all final guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn this year are also listed. We have organized the documents by the issuing Center or Office within FDA, and we have identified the pertinent intended users or regulatory activities. 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 information on the tables below.
The following most frequently used Internet sites for agency guidances are provided for future reference:
CBER: http://www.fda.gov/cber/guidelines.htm
CDER: http://www.fda.gov/cder/guidance/index.htm
CDRH: http://www.fda.gov/cdrh/guidance.html
CFSAN: http://www.cfsan.fda.gov/
dms/guidance.html
CVM: http://www.fda.gov/cvm/guidance/published.htm
#
documents
ORA: http://www.fda.gov/ora/compliance—;ref
II. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
Name of Document
Date of Issuance
Intended User or Regulatory Activity
How to Obtain a Hard Copy of the Document
Interpretative Guidelines of the Source Plasma (Human) Standards
October 2, 1973
FDA Regulated Industry
Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber
Guidelines for Reviewing Amendments to Include Plasmapheresis of Hemophiliacs
July 20, 1976
Do
Do
Package Insert: Immune Serum Globulin (Human)
March 30, 1978
Do
Do
Guidelines for Interpretation of Potency Test Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids
April 12, 1979
Do
Do
Guidelines for Immunization of Source Plasma (Human) Donors With Blood Substances
June 1, 1980
Do
Do
Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)
January 28, 1981
Do
Do
Platelet Testing Guidelines—Approval of New Procedures and Equipment
July 1, 1981
Do
Do
Revised Guideline for Adding Heparin to Empty Containers for Collection of Heparinized Source Plasma (Human)
August 1, 1981
Do
Do
Requirements for Infrequent Plasmapheresis Donors
August 27, 1982
Do
Do
Recommendations to Decrease the Risk of Transmitting AIDS From Plasma Donors
March 24, 1983
Do
Do
PTC in the Manufacture of In Vitro Monoclonal Antibody Products Subject to Licensure
June 20, 1983
Do
Do
Draft PTC in the Production and Testing of Interferon Intended for Investigational Use in Humans (Interferon Test Procedures)
July 28, 1983
Do
Do
Interstate Shipment of Interferon for Investigational Use in Laboratory Research Animals or Tests in Vitro
November 21, 1983
Do
Do
Deferral of Blood Donors Who Have Received the Drug Accutane (Isotretinoin/Roche); 13-cis-retinoic acid)
February 28, 1984
Do
Do
Equivalent Methods for Compatibility Testing
December 14, 1984
Do
Do
Plasma Derived From Therapeutic Plasma Exchange
December 14, 1984
Do
Do
Draft PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology
April 10, 1985
Do
Do
Guidelines for Meningococcal Polysaccharide Vaccines
July 17, 1985
Do
Do
Guideline for the Uniform Labeling of Blood and Blood Components
August 1, 1985
Do
Do
Recommended Methods for Short Ragweed Pollen Extracts
November 1, 1985
Do
Do
Reduction of the Maximum Platelet Storage Period to 5 Days in an Approved Container
June 2, 1986
Do
Do
To In Vitro Diagnostic Reagent Manufacturers: Guidance on the Labeling of Human Blood Derived in Vitro Diagnostic Devices in Regard to Labeling for HTLV-III/LAV Antibody Testing
December 6, 1986
Do
Do
Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics
February 1, 1987
Do
Do
Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics
February 1, 1987
Do
Do
Guideline on General Principles of Process Validation
May 1, 1987
Do
Do
Guideline on Sterile Drug Products Produced by Aseptic Processing
June 1, 1987
Do
Do
Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone
November 25, 1987
Do
Do
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
December 1, 1987
Do
Do
Recommendations for the Management of Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)
December 2, 1987
Do
Do
Extension of Dating Period for Storage of Red Blood Cells, Frozen
December 4, 1987
Do
Do
To Licensed In Vitro Diagnostic Manufacturers: Handling of Human Blood Source Materials
December 23, 1987
Do
Do
Recommendations for Implementation of Computerization in Blood Establishments
April 6, 1988
Do
Do
Control of Unsuitable Blood and Blood Components
April 6, 1988
Do
Do
Discontinuance of Prelicensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines
July 7, 1988
Do
Do
Physician Substitutes
August 15, 1988
Do
Do
To Licensed Manufacturers of Blood Grouping Reagents: Criteria for Exemption of Lot Release
August 26, 1988
Do
Do
Revised Guideline for the Collection of Platelets, Pheresis
October 7, 1988
Do
Do
To Manufacturers of HTLV-I Antibody Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel I
October 18, 1988
Do
Do
Draft Guideline for the Design of Clinical Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses
November 1, 1988
Do
Do
HTLV-I Antibody Testing
November 29, 1988
Do
Do
Use of Recombigen HIV-1 LA Test
February 1, 1989
Do
Do
Guidelines for Release of Pneumococcal Vaccine, Polyvalent
February 1, 1989
Do
Do
Guidance for Autologous Blood and Blood Components
March 15, 1989
Do
Do
HTLV-I Antibody Testing
July 6, 1989
Do
Do
Use of Recombigen HIV-1 Latex Agglutination (LA) Test
August 1, 1989
Do
Do
Draft PTC in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989)
August 8, 1989
Do
Do
PTC in the Collection, Processing and Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans
August 22, 1989
Do
Do
Information Relevant to the Manufacture of Acellular Pertussis Vaccine
August 23, 1989
Do
Do
FDA Regulated Industries for Drug Master Files
September 1, 1989
Do
Do
Requirements for Computerization of Blood Establishments
September 8, 1989
Do
Do
Abbott Laboratories' HIVAG-1 Test for HIV-1 Antigen(s) Not Recommended for Requirements for Computerization of Blood Establishments
October 4, 1989
Do
Do
Guideline for Collection of Blood or Blood Products From Donors With PositiveTests for Infectious Disease Markers (“High Risk” Donors)
October 26, 1989
Do
Do
Guideline for Determination of Residual Moisture in Dried Biological Products
January 1, 1990
Do
Do
Autologous Blood Collection and Processing Procedures
February 12, 1990
Do
Do
Cytokine and Growth Factor Pre-Pivotal Trial Information Package
April 2, 1990
Do
Do
Use of Genetic Systems HIV-2 EIA
June 21, 1990
Do
Do
PTC in the Safety Evaluation of Hemoglobin-Based Oxygen Carriers
August 21, 1990
Do
Do
Guideline on the Preparation of Investigational New Drug Products (Human and Animal)
March 1, 1991
Do
Do
FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica
March 15, 1991
Do
Do
Revision to October 26, 1989, Guideline for Collection of Blood or Blood Products From Donors With Positive Tests for Infectious Disease Markers (High Risk Donors)
March 17, 1991
Do
Do
Deficiencies Relating to the Manufacture of Blood and Blood Components
March 20, 1991
Do
Do
Responsibilities of Blood Establishments Related to Errors and Accidents in the Manufacture of Blood and Blood Components
March 20, 1991
Do
Do
To Biologic Product Manufacturers—Controlling Materials of Bovine or Ovine Origin
May 3, 1991
Do
Do
FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)
September 10, 1991
Do
Do
Disposition of Blood Products Intended for Autologous Use That Test Repeatedly Reactive for Anti-HCV
September 11, 1991
Do
Do
Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing
December 12, 1991
Do
Do
Recommended Methods for Blood Grouping Reagents Evaluation
March 1, 1992
Do
Do
Recommended Methods for Evaluating Potency, Specificity and Reactivity of Anti-Human Globulin
March 1, 1992
Do
Do
PTC in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin
March 1, 1992
Do
Do
PTC in the Manufacture of In Vitro Monoclonal Antibody Products for Further Manufacturing into Blood Grouping Reagent and Anti-Human Globulin
March 1, 1992
Do
Do
Supplement to the PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability
April 6, 1992
Do
Do
Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products
April 23, 1992
Do
Do
Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA)
April 23, 1992
Do
Do
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)
April 23, 1992
Do
Do
Exemptions to Permit Persons With a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma; Alternative Procedures, 21 CFR 640.120
April 23, 1992
Do
Do
Changes in Equipment for Processing Blood Donor Samples
July 21, 1992
Do
Do
Nomenclature for Monoclonal Blood Grouping Reagents
September 28, 1992
Do
Do
Volume Limits for Automated Collection of Source Plasma
November 4, 1992
Do
Do
FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics
November 25, 1992
Do
Do
Revision of October 7, 1988, Memo Concerning Red Blood Cell Immunization Programs
December 16, 1992
Do
Do
Draft PTC in the Characterization of Cell Lines Used to Produce Biologicals
July 12, 1993
Do
Do
CBER Refusal to File (RTF) Guidance for Product and Establishment License Applications
July 12, 1993
Do
Do
Guidance on Alternatives to Lot Release for Licensed Biological Products
July 20, 1993
Do
Do
Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products
July 22, 1993
Do
Do
Deferral of Blood and Plasma Donors Based on Medications
July 28, 1993
Do
Do
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)
August 19, 1993
Do
Do
Changes in Administrative Procedures
September 9, 1993
Do
Do
To Sponsors of INDs Using Retroviral Vectors
September 20, 1993
Do
Do
Draft Guideline for the Validation of Blood Establishment Computer Systems
September 28, 1993
Do
Do
Methods of the Allergenic Products Testing Laboratory
October 1, 1993
Do
Do
Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice
October 14, 1993
Do
Do
Guideline for Adverse Experience Reporting for Licensed Biological Products
October 15, 1993
Do
Do
Guidance Regarding Post Donation Information Reports
December 10, 1993
Do
Do
To Manufacturers: Bovine Derived Materials (BSE)
December 17, 1993
Do
Do
Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis
December 22, 1993
Do
Do
Compliance Program Guidance Manual (Drugs and Biologics)
1994
Do
National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-605-6050 (NTIS Order No. 94-920699)
Recommendations for the Invalidation of Test Results When Using Licensed Viral Marker Assays to Screen Donors
January 3, 1994
Do
Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber
To Sponsors of INDs for Human Immunoglobulin Products
May 23, 1994
Do
Do
To Manufacturers of Licensed Anti-HIV Test Kits
May 26, 1994
Do
Do
Recommendations for Deferral of Donors for Malaria Risk
July 26, 1994
Do
Do
ICH Guideline for Industry: Studies in Support of Special Populations
August 1, 1994
Do
Do
OELPS, Advertising and Promotional Labeling Staff Procedural Guidance Document (Draft)
August 1, 1994
Do
Do
ICH Guideline for Industry: Stability Testing of New Drug Substances and Products
September 1, 1994
Do
Do
Guide to Inspections of Blood Banks, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs
September 1, 1994
FDA Personnel
Do
Letter to Manufacturers of Immune Globulin Intravenous (Human) (IGIV), Aseptic Meningitis Syndrome
October 3, 1994
FDA Regulated Industry
Do
Guidance on Alternatives to Lot Release for Licensed Biological Products
October 27, 1994
Do
Do
Guidance for Industry: For the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances
November 1994
Do
Do
Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems
December 20, 1994
Do
Do
To Manufacturers of Immune Globulin Products: Testing for Hepatitis C Virus RNA Immunoglobulin
December 27, 1994
Do
Do
Timeframe for Licensing Irradiated Blood Products
February 3, 1995
Do
Do
Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous Guidance
February 23, 1995
Do
Do
ICH Guideline for Industry: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
March 1, 1995
Do
Do
To Manufacturers of Intramuscular Immune Globulin Products: HCV RNA Testing by PCR
March 3, 1995
Do
Do
Revision of 8/27/82 FDA Memo: Requirements for Infrequent Plasmapheresis Donors
March 10, 1995
Do
Do
To Manufacturers of Intramuscular Immune Globulin Products: Additional Information Regarding HCV RNA Testing by PCR
March 13, 1995
Do
Do
To Health Professionals: Implementation of Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular Administration
March 14, 1995
Do
Do
To All Establishments Performing Red Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma
March 14, 1995
Do
Do
Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source Plasma
June 8, 1995
Do
Do
Guideline for Quality Assurance in Blood Establishments
July 11, 1995
Do
Do
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products
July 11, 1995
Do
Do
Disposition of Products Derived From Donors Diagnosed With, or at Known High Risk for, Creutzfeldt-Jakob Disease
August 8, 1995
Do
Do
Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained From Donors With Elevated Levels of Alanine Aminotransferase (ALT)
August 8, 1995
Do
Do
Precautionary Measures to Further Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease by Blood and Blood Products
August 8, 1995
Do
Do
Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen
August 8, 1995
Do
Do
PTC in the Manufacture and Testing of Therapeutic Products for Human Use Derived From Transgenic Animals
August 22, 1995
Do
Do
Informed Consent for Plasmapheresis/Immunization
October 1, 1995
FDA Personnel
Do
Draft Reviewers' Guide: Changes in Personnel
October 1, 1995
FDA Personnel
Do
Disease Associated Antibody Collection Program
October 1, 1995
FDA Personnel
Do
Guidance Concerning Conversion to FDA-Reviewed Software Products
November 13, 1995
FDA Regulated Industry
Do
Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis
December 4, 1995
Do
Do
Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products
December 8, 1995
Do
Do
Dear Colleague: Regarding Reverse Transcriptase Activity in Viral Vaccines Produced in Chicken Cells
January 4, 1996
Do
Do
Requesting All Manufacturers Immediately to Revise Warning Section for Package Insert on Thrombin
January 4, 1996
Do
Do
ICH Final Guideline: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Dervied Protein Products
February 23, 1996
Do
Do
ICH Final Guideline on the Need for Long-Term Rodent Carcinogenicity Study of Pharmaceuticals
March 1, 1996
Do
Do
Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen
March 14, 1996
Do
Do
FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products
March 26, 1996
Do
Do
ICH Guideline on the Detection of Toxicity to Reproduction for Medicinal Products; Addendum on Toxicity to Male Fertility
April 5, 1996
Do
Do
ICH Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
April 24, 1996
Do
Do
To Manufacturers of FDA-Regulated Drug/Biological/Device Products, Bovine Spongiform Encephalopathy (BSE)
May 9, 1996
Do
Do
Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)
May 16, 1996
Do
Do
Guidance for Industry—The Content and Format for Pediatric Use Supplements
May 23, 1996
Do
Do
Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of Reconstruction
May 24, 1996
Do
Do
Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products
May 29, 1996
Do
Do
Guide to Inspections of Infectious Disease Marker Testing Facilities
June 1, 1996
FDA Personnel
Do
To Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Polymerase Chain Reaction (PCR) of Intramuscular Immune Globulin Preparations
June 13, 1996
FDA Regulated Industry
Do
ICH Final Guidelines on Stablity Testing of Biotechnological/Biological Products
July 10, 1996
ICH Guideline on Structure and Content of Clinical Study Reports
July 17, 1996
Do
Do
Recommendations for the Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)
July 19, 1996
Do
Do
To Manufacturers: HIV-1 Group O
July 31, 1996
Do
Do
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
August 15, 1996
Do
Do
ICH Revised Guidance: Single Dose Acute Toxicity Testing for Pharmaceuticals
August 26, 1996
Do
Do
ICH Draft Guideline on Data Elements for Transmission of Individual Case Reports
October 1, 1996
Do
Do
To All Plasma Derivative Manufacturers and to ABRA: Warning Statement for Plasma Derivative Product Labeling
October 7, 1996
Do
Do
Advertising and Promotion; Guidance; Notice
October 8, 1996
Do
Do
To Biologic Product Manufacturers: Revised Procedures for Internal Labeling Review Number Assignment
December 3, 1996
Do
Do
Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection
December 11, 1996
Do
Do
PTC on Plasmid DNA Vaccines for Preventive Infectious Disease Indications
December 22, 1996
Do
Do
Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products
January 1997
Do
Do
Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software
January 13, 1997
FDA Personnel
Do
PTC in the Manufacturing and Testing of Monoclonal Antibody Products for Human Use
February 28, 1997
Do
Do
Proposed Approach to Regulation of Cellular and Tissue-Based Products
February 27, 1997
Do
Do
Tables 1 and 2 From Proposed Approach to Regulation of Cellular and Tissue-Based Products
March 4, 1997
Do
Do
Preclearance of Promotional Labeling; Clarification
March 5, 1997
Do
Do
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies
April 1997
Do
Do
ICH Draft Guideline on Dose Selection for Carcinogenicity Studies for Pharmaceuticals: Addendum on the Limit Dose
April 2, 1997
Do
Do
ICH Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
May 2, 1997
Do
Do
ICH Draft Guideline on Impurities: Residual Solvents
May 2, 1997 (Correction May 19, 1997)
Do
Do
ICH Guideline on Stability Testing for New Dosage Forms
May 9, 1997
Do
Do
ICH Draft Guideline on Statistical Principles for Clinical Trials, Part III
May 9, 1997
Do
Do
ICH Good Clinical Practice: Consolidated Guideline, Part II
May 9, 1997
Do
Do
ICH Guideline for the Photostability Testing of New Drug Substances and Products, Part II
May 16, 1997
Do
Do
ICH Guideline on Impurities in New Drug Products, Part IV
May 19, 1997
Do
Do
ICH Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, Part VI
May 19, 1997
Do
Do
ICH Guideline on the Validation of Analytical Procedures: Methodology, Part V
May 19, 1997
Do
Do
To Plasma Fractionators—CBER's View on Product Recalls Conducted by the Plasma Fractionation Industry
May 29, 1997
Do
Do
ICH Draft Guideline on General Considerations for Clinical Trials
May 30, 1997
Do
Do
Guide to Inspections of Source Plasma Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs)
June 1, 1997
FDA Personnel
Do
Draft Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability
June 18, 1997
FDA Regulated Industry
Do
Guidance for Industry—Changes to an Approved Application: Biological Products
July 1997
Do
Do
Guidance for Industry—Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
July 1997
Do
Do
Guidance for Industry—Screening and Testing of Donors of Human Tissue Intended for Transplantation
July 1997
Do
Do
Guidance for Industry—Donor Screening for Antibodies to HTLV-II
August 1997
Do
Do
Guidance for Industry—Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report
August 1997
Do
Do
Draft Guidance for Industry Efficacy Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers
September 1997
Do
Do
Guidance for Industry—The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use
September 1997
Do
Do
Notification Process for Transfusion Related Fatalities and Donation Related Deaths (revised telephone number)
October 7, 1997
Do
Do
Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries
October 15, 1997
Do
Do
ICH Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
November 18, 1997
Do
Do
ICH Guidance on Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals
November 21, 1997
Do
Do
ICH Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
November 25, 1997
Do
Do
Guidance for FDA and Industry: Direct Final Rule Procedures
November 21, 1997
FDA Personnel and Regulated Industry
Do
Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS)
December 1997
FDA Regulated Industry
Do
Guidance for Industry: Industry-Supported Scientific and Educational Activities
December 3, 1997
Do
Do
ICH Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes
December 4, 1997
Do
Do
To Biologic Product Manufacturers—Withdrawal of Human Blood-Derived Materials Because Donors Diagnosed With, or at Increased Risk for, CJD
December 11, 1997
Do
Do
To Allergenic Extract Manufacturers—Standardized Grass Pollen Extracts
December 23, 1997
Do
Do
ICH Guidance on Data Elements for Transmission of Individual Case Safety Reports
January 15, 1998
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products
January 1998
Do
Do
Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
January 1998
Do
Do
ICH Guidance on Testing for Carcinogenicity of Pharmaceuticals
February 28, 1998
Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients
March 1998
Do
Do
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy
March 1998
Do
Do
Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research
May 1998
Do
Do
Draft Guidance for Industry: Pilot Program for Electronic Investigational New Drug (eIND) Applications for Biological Products
May 1998
Do
Do
Guidance for Industry: Classifying Resubmissions in Response to Action Letters
May 1998
Do
Do
Guidance for Industry: Pharmacokinetics in Patients With Impaired Renal Function—Study Design, Data Analysis and Impact on Dosing and Labeling
May 1998
Do
Do
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements
May 1998
Do
Do
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products
May 1998
Do
Do
Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products
June 1998
Do
Do
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
June 1998
Do
Do
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing
June 1998
Do
Do
ICH Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
June 9, 1998
Do
Do
ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data
June 10, 1998
Do
Do
Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996
June 12, 1998
Do
Do
Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements
July 1998
Do
Do
Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications
July 1998
Do
Do
Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV
September 1998
Do
Do
Draft Guidance for Industry: Submitting Debarment Certification Statements
September 1998
Do
Do
Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1)
September 1998
Do
Do
Guidance for Industry: Fast Track Drug Development Programs—Designation, Development, and Application Review
September 1998
Do
Do
ICH Guidance on Statistical Principles for Clinical Trials
September 16, 1998
Do
Do
ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
September 21, 1998
Do
Do
ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
September 24, 1998
Do
Do
Guidance for Industry: On Advisory Committees: Implementing Section 120 of the Food and Drug Administration Act of 1997
October 1998
Do
Do
Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products
November 1998
Do
Do
To Viral Vaccine IND Sponsors—Use of PCR-Based Reverse Transcriptase Assay
December 18, 1998
Do
Do
Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
December 1998
Do
Do
Draft Guidance for Industry: Content and Format of Geriatric Labeling
December 1998
Do
Do
Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional Labeling
January 1999
Do
Do
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product
January 1999
Do
Do
Guidance on Amended Procedures for Advisory Panel Meetings
January 1999
Do
Do
Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General Considerations
January 1999
Do
Do
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
February 1999
Do
Do
Guidance for Industry: Population Pharmacokinetics
February 1999
Do
Do
Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
February 1999
Do
Do
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
February 1999
Do
Do
Draft Guidance for Industry: INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufacturing and Controls Content and Format
February 1999
Do
Do
Draft Guidance for Industry: Accelerated Approval Products—Submission of Promotional Materials
March 1999
Do
Do
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product
March 1999
Do
Do
Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans
April 1999
Do
Do
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
April 1999
Do
Do
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”
May 1999
Do
Do
Guidance for Industry for Platelet Testing and Evaluation of Platelet Substitute Products
May 1999
Do
Do
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
May 1999
Do
Do
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation
May 1999
Do
Do
Draft Guidance for Industry: Establishing Pregnancy Registries
June 1999
Do
Do
Draft Reviewer Guidance: Evaluation of Human Pregnancy Outcome Data
June 1999
FDA Personnel
Do
Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)
June 1999
FDA Regulated Industry
Do
ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)
June 25, 1999
Do
Do
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)
July 1999
Do
Do
Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
July 1999
Do
Do
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
August 1999
Do
Do
Guidance for Industry: Consumer-Directed Broadcast Advertisements
August 1999
Do
Do
Draft Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act
August 1999
Do
Do
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products
August 1999
Do
Do
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
August 1999
Do
Do
ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
August 18, 1999
Do
Do
Draft Guidance for Industry: Revised Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors
September 1999
Do
Do
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
September 1999
Do
Do
International Conference on Harmonisation Draft Guidance; Choice of Control Group in Clinical Trials
September 24, 1999
Do
Do
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format—Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]—Revised
November 1999
Do
Do
Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products
November 1999
Do
Do
Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis and Recommendations for Dosing and Labeling
November 1999
Do
Do
Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma
November 1999
Do
Do
Draft Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis and Impact on Dosing and Labeling
November 1999
Do
Do
International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common Technical Document
November 8, 1999
Do
Do
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
December 1999
Do
Do
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
December 1999
Do
Do
Draft Guidance for Industry: Special Protocol Assessment
December 1999
Do
Do
Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
January 2000
Do
Do
Draft Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
February 2000
FDA Personnel
Do
Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information
February 2000
FDA Regulated Industry
Do
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products
February 2000
Do
Do
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level
February 2000
Do
Do
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing
February 2000
Do
Do
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank
March 2000
Do
Do
International Conference on Harmonisation; Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products
April 21, 2000
Do
Do
Draft Guidance for Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics
May 2000
Do
Do
Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components
June 2000
Do
Do
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria
June 2000
Do
Do
Draft Guidance for Industry: Pediatric Oncology Studies in Response to a Written Request
June 2000
Do
Do
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use With Cadaveric Blood Specimens (Level 2)
June 2000
Do
Do
Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment
June 2000
Do
Do
Draft Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside Supplier
June 2000
Do
Do
Draft Guidance for Industry: Developing Medical Imaging Drugs and Biological Products
June 2000
Do
Do
International Conference on Harmonisation (ICH) Draft Guidance; Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (March 17, 2000)
June 2000
Do
Do
International Conference on Harmonisation (ICH) Draft Revised Guidance on Impurities in New Drug Products
July 19, 2000
Do
Do
International Conference on Harmonisation (ICH) Draft Revised Guidance on Impurities in New Drug Substances
July 20, 2000
Do
Do
International Conference on Harmonisation (ICH) Draft Guideline: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
July 20, 2000
Do
Do
International Conference on Harmonisation (ICH) Draft Guideline on Safety Pharmacology Studies for Human Pharmaceuticals
August 2000
Do
Do
Draft Guidance for Industry: Analytical Procedures and Methods Validation—Chemistry, Manufacturing, and Controls Documentation
August 2000
Do
Do
Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications
August 2000
Do
Do
Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
October 2000
Do
Do
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
October 2000
Do
Do
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds
October 2000
Do
Do
Draft Guidance for Industry: Cancer Drug and Biological Products—Clinical Data in Marketing Applications
November 2000
Do
Do
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
November 2000
Do
Do
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices (Level 2)
November 2000
Do
Do
Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))
November 2000
Do
Do
International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population
December 2000
Do
Do
Draft Guidance for Industry: Variances for Blood Collection From Individuals With Hereditary Hemochromatosis
December 2000
Do
Do
Draft Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees
December 2000
Do
Do
International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
December 29, 2000
Do
Do
PHS Guideline on Infectious Disease Issues in Xenotransplantation
January 19, 2001
Do
Do
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion
January 2001
Do
Do
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
January 2001
Do
Do
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling
January 2001
Do
Do
Draft Guidance for Industry: Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
February 2001
Do
Do
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods—Technical Correction February 2001
February 2001
Do
Do
Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research
February 2001
Do
Do
Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
March 2001
Do
Do
Guidance for Industry: Acceptance of Foreign Clinical Studies
March 2001
Do
Do
Guidance for Industry: Financial Disclosure by Clinical Investigators
March 2001
Do
Do
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing
March 2001
Do
Do
Draft Guidance for Industry: Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
April 2001
Do
Do
Draft Guidance for Industry: Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements
April 2001
Do
Do
Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
April 2001
Do
Do
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports
May 2001
Do
Do
Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials
May 2001
Do
Do
Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information
May 2001
Do
Do
III. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
Name of Document
Date of Issuance
Intended User or Regulatory Activity
How to Obtain a Hard Copy of the Document
Accelerated Approval Products—Submission of Promotional Materials—Draft
March 26, 1999
Advertising Draft
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Product Name, Placement, Size, and Prominence in Advertising and Promotional Labeling—Draft
March 12, 1999
Do
Do
Promoting Medical Products in a Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies—Draft
January 5, 1998
Do
Do
Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements—Draft
April 23, 2001
Do
Do
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling
January 12, 1998
Advertising
Do
Consumer-Directed Broadcast Advertisements
August 9, 1999
Do
Do
Industry-Supported Scientific and Educational Activities
December 3, 1997
Do
Do
Antifungal (Topical)—Draft
February 24, 1990
Biopharmaceutic Draft
Do
Antifungal (Vaginal)—Draft
February 24, 1990
Do
Do
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action—Draft
June 2, 1999
Do
Do
Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence—Draft
March 9, 2000
Do
Do
Food-Effect Bioavailability and Bioequivalence Studies—Draft
December 30, 1997
Do
Do
In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies—Draft
December 10, 1997
Do
Do
Topical Dermatological Drug Product NDAs and ANDAs—In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies—Draft
June 18, 1998
Do
Do
Bioanalytical Method Validation
May 23, 2001
Biopharmaceutic
Do
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations
October 27, 2000
Do
Do
Cholestyramine Powder In Vitro Bioequivalence
July 15, 1993
Do
Do
Clozapine (Tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing
November 15, 1996
Do
Do
Corticosteroids, Detmatologic (Topical) In Vivo
June 2, 1995
Do
Do
Dissolution Testing of Immediate Release Solid Oral Dosage Forms
August 25, 1997
Do
Do
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
September 26, 1997
Do
Do
Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing
March 8, 2001
Do
Do
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro
June 27, 1989
Do
Do
Phenytoin/Phenytion Sodium (Capsules, Tablets, Suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing
March 4, 1994
Do
Do
Potassium Chloride (Slow-Release Tablets and Capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing
June 6, 1994
Do
Do
Statistical Approaches to Establishing Bioequivalence
February 2, 2001
Do
Do
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
August 31, 2000
Do
Do
Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation—Draft
August 30, 2000
Chemistry Draft
Do
Botanical Drug Products—Draft
August 11, 2000
Do
Do
INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufacturing, and Controls Content and Format—Draft
April 20, 1999
Do
Do
Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation—Draft
November 19, 1998
Do
Do
Monoclonal Antibodies Used as Reagents in Drug Manufacturing—Draft
June 24, 1999
Do
Do
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Draft
June 2, 1999
Do
Do
Stability Testing of Drug Substances and Drug Products—Draft
June 8, 1998
Do
Do
Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications—Draft
November 1, 1991
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum—Draft
January 5, 1999
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Tracking of NDA and NDA Reformulations for Solid, Oral, Immediate Release Drug Products—Draft
April 12, 1989
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
BACPAC1: Intermediates in Drug Substance Synthesis: Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
February 16, 2001
Chemistry
Do
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
July 24, 1997
Do
Do
Changes to an Approved NDA or ANDA
November 23, 1999
Do
Do
Changes to an Approved NDA or ANDA: Questions and Answers
January 22, 2001
Do
Do
Container Closure Systems for Packaging Human Drugs and Biologics
July 7, 1999
Do
Do
Development of New Stereoisomeric Drugs
May 1, 1992
Do
Do
Drug Master Files
September 1, 1989
Do
Do
Drug Master Files for Bulk Antibiotic Drug Substances
November 29, 1999
Do
Do
Environmental Assessment of Human Drugs and Biologics Applications
July 27, 1998
Do
Do
Format and Content for the CMC Section of an Annual Report
September 1, 1994
Do
Do
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
February 1, 1987
Do
Do
Format and Content of the Microbiology Section of an Application
February 1, 1987
Do
Do
IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information
May 25, 2001
Do
Do
Monoclonal Antibodies Used as Reagents in Drug Manufacturing
March 29, 2001
Do
Do
NDAs: Impurities in Drug Substances
February 25, 2000
Do
Do
PAC-ALTS: Postapproval Changes—Analytical Testing Laboratory Sites
April 28, 1998
Do
Do
Reviewer Guidance: Validation of Chromatographic Methods
November 1, 1994
Do
Do
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances
November 1, 1994
Do
Do
Submission of Documentation for Sterilization Process Validation Applications for Human and Veterinary Drug Products
November 1, 1994
Do
Do
Submitting Documentation for the Manufacturing of and Controls for Drug Products
February 1, 1987
Do
Do
Submitting Documentation for the Stability of Human Drugs and Biologics
February 1, 1987
Do
Do
Submitting Samples and Analytical Data for Methods Validation
February 1, 1987
Do
Do
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products
February 1, 1987
Do
Do
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
February 1, 1987
Do
Do
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
November 30, 1995
Do
Do
SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
February 26, 1999
Do
Do
SUPAC-IR: Questions and Answers
February 18, 1997
Do
Do
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
October 6, 1997
Do
Do
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
June 13, 1997
Do
Do
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy
December 20, 2000
Do
Do
Acute Bacterial Exacerbation of Chronic Bronchitis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Clinical Antimicrobial Draft
Do
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Acute Bacterial Sinusitis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Acute Otitis Media; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for Treatment—Draft
October 18, 1999
Do
Do
Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements—Draft
September 1, 1999
Do
Do
Community Acquired Pneumonia; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Complicated Urinary Tract Infections and Pylonephritis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Developing Antimicrobial Drugs—General Considerations for Clinical Trials—Draft
July 22, 1998
Do
Do
Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products—Draft
February 17, 1997
Do
Do
Lyme Disease; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Nosocomial Pneumonia; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Secondary Bacterial Infections of Acute Bronchitis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Uncomplicated and Complicated Skin and Skin Structure Infections; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Uncomplicated Gonorrhea—Cervical, Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment—Draft
July 22, 1998
Do
Do
Clinical Development and Labeling of Anti-Infective Drug Products
October 26, 1992
Clinical Antimicrobial
Do
Clinical Evaluation of Anti-Infective Drugs (Systemic)
September 1, 1977
Do
Do
Preclinical Development of Antiviral Drugs
November 1, 1990
Do
Do
Abuse Liability Assessment—Draft
July 1, 1990
Clinical Medical Draft
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Allergic Rhinitis: Clinical Development Programs for Drug Products—Draft
June 21, 2000
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Cancer Drug and Biological Products—Clinical Data in Marketing Applications—Draft
November 9, 2000
Do
Do
Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment—Draft
June 28, 2000
Do
Do
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)—Draft
July 15, 1999
Do
Do
Clinical Evaluation of Anti-Anginal Drugs—Draft
January 1, 1989
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Anti-Arrhythmic Drugs—Draft
July 1, 1985
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Antihypertensive Drugs—Draft
May 1, 1988
Do
Do
Clinical Evaluation of Drugs for the Treatment of Congestive Heart Failure—Draft
December 1, 1987
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Drugs for Ulcerative Colitis (3rd draft)—Draft
January 7, 1991
Do
Do
Clinical Evaluation of Lipid-Altering Agents In Adults and Children—Draft
September 1, 1990
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Motility-Modifying Drugs—Draft
Date not available
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Weight-Control Drugs—Draft
September 24, 1996
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Developing Medical Imaging Drugs and Biologics—Revised—Draft
July 31, 2000
Do
Do
Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use Disorders—Draft
February 12, 1992
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Development of Parathyroid Hormones for the Prevention and Treatment of Osteoporosis—Draft
June 14, 2000
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Establishing Pregnancy Registries—Draft
June 4, 1999
Do
Do
Evaluation of Human Pregnancy Outcome Data—Draft
June 4, 1999
Do
Do
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment—Draft
May 19, 2000
Do
Do
Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research—Draft
March 30, 2000
Do
Do
OTC Treatment of Herpes Labialis With Antiviral Agents—Draft
March 8, 2000
Do
Do
Pediatric Oncology Studies in Response to a Written Request—Draft
June 21, 2000
Do
Do
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines—Draft
March 12, 2001
Do
Do
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis—Draft
April 1, 1994
Do
Do
Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals—Draft
September 1, 1991
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Recommendations for Complying With the Pediatric Rule—Draft
December 4, 2000
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
System Inflammatory Response Syndrome (SIRS) (1st draft)—Draft
July 1993
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Acceptance of Foreign Clinical Studies
March 13, 2001
Clinical Medical
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
February 17, 1999
Do
Do
Clinical Development Programs for MDI and DPI Drug Products
September 19, 1994
Do
Do
Clinical Evaluation of Analgesic Drugs
December 1, 1992
Do
Do
Clinical Evaluation of Antacid Drugs
April 1, 1978
Do
Do
Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (Adults and Children)
April 1, 1988
Do
Do
Clinical Evaluation of Antianxiety Drugs
September 1, 1977
Do
Do
Clinical Evaluation of Antidepressant Drugs
September 1, 1977
Do
Do
Clinical Evaluation of Antidiarrheal Drugs
September 1, 1977
Do
Do
Clinical Evaluation of Antiepileptic Drugs (Adults and Children)
January 1, 1981
Do
Do
Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women
March 20, 1995
Do
Do
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs
September 1, 1977
Do
Do
Clinical Evaluation of General Anesthetics
May 1, 1982
Do
Do
Clinical Evaluation of Hypnotic Drugs
September 1, 1977
Do
Do
Clinical Evaluation of Laxative Drugs
April 1, 1978
Do
Do
Clinical Evaluation of Local Anesthetics
May 1, 1982
Do
Do
Clinical Evaluation of Psychoactive Drugs in Infants and Children
July 1, 1979
Do
Do
Clinical Evaluation of Radiopharmaceutical Drugs
October 1, 1981
Do
Do
Content and Format for Pediatric Use Supplements
May 24, 1996
Do
Do
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
November 20, 1995
Do
Do
Development of Vaginal Contraceptive Drugs (NDA)
April 19, 1995
Do
Do
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
February 2, 1999
Do
Do
FDA Requirements for Approval of Drugs to Treat Non-Small Lung Cancer
January 29, 1991
Do
Do
FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer
June 20, 1989
Do
Do
Format and Content of the Clinical and Statistical Sections of an Application
July 1, 1988
Do
Do
Format and Content of the Summary for New Drug and Antibiotic Applications
February 1, 1987
Do
Do
Formatting, Assembling and Submitting New Drug and Antibiotic Applications
February 1, 1987
Do
Do
General Considerations for the Clinical Evaluation of Drugs
December 1, 1978
Do
Do
General Considerations for the Clinical Evaluation of Drugs in Infants and Children
September 1, 1977
Do
Do
Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing
March 8, 2001
Do
Do
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer
April 13, 1988
Do
Do
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer
April 19, 1988
Do
Do
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products; Clarification of What to Report
August 27, 1997
Do
Do
Postmarketing Reporting of Adverse Drug Experiences
March 1, 1992
Do
Do
Preclinical Development of Immunomodulatory Drugs for the Treatment of HIV Infection and Associated Disorders
September 4, 1992
Do
Do
Preparation of Investigational New Drug Products (Human and Animal)
November 1, 1992
Do
Do
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
May 15, 1998
Do
Do
Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs
July 22, 1993
Do
Do
Study of Drugs Likely To Be Used in the Elderly
November 1, 1989
Do
Do
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
September 13, 1999
Do
Do
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products—Draft
November 30, 1998
Clinical Pharmacology Draft
Do
Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling—Draft
December 7, 1999
Do
Do
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro
April 7, 1997
Clinical Pharmacology
Do
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application
February 1, 1987
Do
Do
In Vivo Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling
November 24, 1999
Do
Do
Pharmacokinetics and Pharmacodynamics in Patients With Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
May 15, 1998
Do
Do
Population Pharmacokinetics
February 10, 1999
Do
Do
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24)—Draft
March 30, 2000
Compliance Draft
Do
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production—Draft
September 30, 1998
Do
Do
Manufacture, Processing or Holding of Active Pharmaceutical Ingredients—Draft
April 17, 1998
Do
Do
Repacking of Solid Oral Dosage Form Drug Products—Draft
February 1, 1992
Do
Do
A Review of FDA’s Implementation of the Drug Export Amendments of 1986
Compliance
Do
Compressed Medical Gases
December 1, 1989
Do
Do
Computerized Systems Used in Clinical Trials
May 10, 1999
Do
Do
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
June 27, 1997
Do
Do
General Principles of Process Validation
May 1, 1987
Do
Do
Good Laboratory Practice Regulations Questions and Answers
Do
Do
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities
April 6, 2001
Do
Do
Monitoring of Clinical Investigations
January 1, 1988
Do
Do
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment
May 1, 1984
Do
Do
Possible Dioxin/PCB Contamination of Drug and Biological Products
August 23, 1999
Do
Do
Sterile Drug Products Produced by Aseptic Processing
May 1, 1987
Do
Do
Street Drug Alternatives
April 3, 2000
Do
Do
Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
December 1, 1987
Do
Do
Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports—Draft
May 4, 2001
Electronic Submission Draft
Do
Providing Regulatory Submissions in Electronic Format: Prescription Drug Advertising and Promotional Labeling—Draft
January 31, 2001
Do
Do
Preparing Data for Electronic Submissions in ANDAs
September 23, 1999
Electronic Submission
Do
Regulatory Submissions in Electronic Format; General Considerations
January 28, 1999
Do
Do
Regulatory Submissions in Electronic Format; New Drug Applications
January 28, 1999
Do
Do
ANDAs; Blend Uniformity Analysis—Draft
August 26, 1999
Generic Drug Draft
Do
ANDAs; Impurities in Drug Products—Draft
January 5, 1999
Do
Do
Content and Format of an Abbreviated New Drug Application (ANDA)—Positron Emission Tomography (PET) Drug Products—With Specific Information for ANDAs for Fludeoxyglucose F18 Injection—Draft
April 18, 1997
Do
Do
Alternate Source of Active Pharmaceutical Ingredients in Pending ANDAs—Draft
December 12, 2000
Do
Do
ANDAs: Impurities in Drug Substances
December 3, 1999
Generic Drugs
Do
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
March 30, 2000
Do
Do
Letter Announcing That the OGD Will Now Accept the ICH Long-Term Storage Conditions as Well as the Stability Studies Conducted in the Past
August 18, 1995
Do
Do
Letter Describing Efforts by CDER and 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
October 14, 1994
Do
Do
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
April 8, 1994
Do
Do
Letter on the Provision of New Information Pertaining to New Bioequivalence Guidelines and Refuse-to-File Letters
July 1, 1992
Do
Do
Letter on the Provision of New Procedures and Policies Affecting the Generic Drug Review Process
March 15, 1989
Do
Do
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
November 8, 1991
Do
Do
Letter on the Response to 12/20/84 Letter From the Pharmaceutical Manufacturers Association About the Drug Price Competition and Patent Term Restoration Act
March 26, 1985
Do
Do
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
January 15, 1993
Do
Do
Letter to Regulated Industry Notifying Interested Parties About Important Detailed Information Regarding Labeling, Scale-up, Packaging, Minor/major Amendment Criteria, and Bioequivalence Requirements
August 4, 1993
Do
Do
Major, Minor, Facsimile, and Telephone Amendments to Original Abbreviated New Drug Applications (Revised)
May 1, 2000
Do
Do
Organization of an ANDA
March 2, 1999
Do
Do
Revising ANDA Labeling Following Revision of the RLD Labeling
April 25, 2000
Do
Do
Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products
February 3, 2000
Do
Do
Variations in Drug Products That May Be Included ANDA
January 27, 1999
Do
Do
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review—Draft
November 22, 1996
Good Review Practices Draft
Do
Pharmacology/Toxicology Review Format
May 10, 2001
Good Review Practices
Do
Q1A(R)—Stability Testing of New Drug Substances and Products—Draft
April 21, 2000
ICH Draft—Quality
Do
Q3A(R)—Impurities in New Drug Substances—Draft
July 20, 2000
Do
Do
Q3B(R)—Impurities in New Drug Products—Draft
July 19, 2000
Do
Do
Q6A—Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances—Draft
November 25, 1997
Do
Do
Q7A—Good Manufacturing Practice for Active Pharmaceutical Ingredients—Draft
August 1, 2000
Do
Do
S7—Safety Pharmacology Studies for Human Pharmaceuticals—Draft
August 7, 2000
ICH Draft—Safety
Do
E12 A—Principles for Clinical Evaluation of New Antihypertensive Drugs—Draft
August 9, 2000
ICH Draft—Efficacy
Do
M4—Common Technical Document—Draft
August 24, 2000
ICH Draft—Joint Safety/Efficacy (Multidisciplinary)
Do
Q1A—Stability Testing of New Drug Substances and Products
September 22, 1994
ICH—Quality
Do
QIB—Photostability Testing of New Drug Substances and Products
May 16, 1997
Do
Do
QIC—Stability Testing for New Dosage Forms
May 9, 1997
Do
Do
Q2A—Text on Validation of Analytical Procedures
March 1, 1995
Do
Do
Q2B—Validation of Analytical Procedures: Methodology
May 19, 1997
Do
Do
Q3A—Impurities in New Drug Substances
January 4, 1996
Do
Do
Q3B(R)— Impurities in New Drug Products
July 19, 2000
Do
Do
Q3C—Impurities: Residual Solvents
December 24, 1997
Do
Do
Q5A—Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
September 24, 1998
Do
Do
Q5B—Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
February 23, 1996
Do
Do
Q5C—Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological Products
July 10, 1996
Do
Do
Q5D—Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
September 21, 1998
Do
Do
Q6A—Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
December 29, 2000
Do
Do
Q6B—Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
August 18, 1999
Do
Do
S1A—The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals
March 1, 1996
ICH—Safety
Do
S1B—Testing for Carcinogenicity in Pharmaceuticals
February 23, 1998
Do
Do
S1C—Dose Selection for Carcinogenicity Studies of Pharmaceuticals
March 1, 1995
Do
Do
S1C(R)—Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes
December 4, 1997
Do
Do
S2A—Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
April 24, 1996
Do
Do
S2B—Genotoxicity: Standard Battery Testing
November 21, 1997
Do
Do
S3A—Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
March 1, 1995
Do
Do
S3B—Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
March 1, 1995
Do
Do
S4A—Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)
June 25, 1999
Do
Do
S5A—Detection of Toxicity to Reproduction for Medicinal Products
September 22, 1994
Do
Do
S5B—Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility
April 5, 1996
Do
Do
S6—Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
November 18, 1997
Do
Do
S7A—Safety Pharmacology Studies for Human Pharmaceuticals
July 13, 2001
Do
Do
EIA—The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions
March 1, 1995
ICH—Efficacy
Do
E2A—Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
March 1, 1995
Do
Do
E2B—Data Elements for Transmission of Individual Case Safety Reports
January 15, 1998
Do
Do
E2C—Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
May 19, 1997
Do
Do
E3—Structure and Content of Clinical Study Reports
July 17, 1996
Do
Do
E4—Dose-Response Information to Support Drug Registration
November 9, 1994
Do
Do
E5—Ethnic Factors in the Acceptability of Foreign Clinical Data
June 10, 1998
Do
Do
E6—Good Clinical Practice: Consolidated Guideline
May 9, 1997
Do
Do
E7—Studies in Support of Special Populations: Geriatrics
August 2, 1994
Do
Do
E8—General Considerations for Clinical Trials
December 24, 1997
Do
Do
E9—Statistical Principles for Clinical Trials
September 16, 1998
Do
Do
E10—International Conference on Harmonisation: Choice of Control Group and Related Issues in Clinical Trials
May 14, 2001
Do
Do
E11—Clinical Investigation of Medicinal Products in the Pediatric Population
December 15, 2000
Do
Do
M3—Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
November 25, 1997
ICH—Joint Safety/Efficacy (Multidisciplinary)
Do
A Revision in Sample Collection Under the Compliance Program Pertaining to Pre-Approval Inspections
July 15, 1996
Industry Letters
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Certification Requirements for Debarred Individuals in Drug Applications
June 1, 1990
Do
Do
Continuation of a Series of Letters Communicating Interim and Informal Generic Drug Policy and Guidance. Availability of Policy and Procedure Guides, and Further Operational Changes to the Generic Drug Review Program
March 2, 1998
Do
Http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Fifth of a Series of Letters Providing Informal Notice About the Act, Discussing the Statutory Mechanism by Which ANDA Applicants May Make Modifications in Approved Drugs Where Clinical Data Is Required
April 10, 1987
Do
Do
Fourth of a Series of Letters Providing Informal Notice to Affected Parties About Policy Developments and Interpretations Regarding the Act. Three-Year Exclusivity Provisions of Title 1
October 31, 1986
Do
Do
Implementation of the Drug Price Competition and Patent Term Restoration Act; Preliminary Guidance
October 11, 1984
Do
Do
Implementation Plan USP Injection Nomenclature
October 2, 1995
Do
Do
Instructions for Filing Supplements Under the Provisions of SUPAC-IR
April 11, 1996
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Seventh of a Series of Letters About the Act Providing Guidance on the “180-Day Exclusivity” Provision of Section 505(j)(4)(B)(iv) of the Act
July 29, 1988
Do
Http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Sixth of a Series of Informal Notice Letters About the Act Discussing 3- and 5-year Exclusivity Provisions of Section 505(c)(3)(D) and (j)(4)(D) of the Act
April 28, 1988
Do
Do
Streamlining Initiative
December 24, 1996
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Supplement to 10/11/84 Letter About Policies, Procedures and Implementation of the Act (Q & A Format)
November 16, 1984
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Third of a Series of Letters Regarding the Implementation of the Act
May 1, 1985
Do
Do
Y2K Letter From Dr. Janet Woodcock
October 19, 1998
Do
Do
Combined Oral Contraceptives—Labeling for Healthcare Providers and Patients—Draft
July 10, 2000
Labeling Draft
Do
Content and Format for Geriatric Labeling—Draft
January 21, 1999
Do
Do
Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics—Draft
June 21, 2000
Do
Do
Non-Contraceptive Estrogen Drug Products—Physician and Patient Labeling—Draft
January 8, 1999
Do
Do
Noncontraceptive Estrogen Class Labeling—Draft
September 27, 1999
Do
Do
Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)—Draft
July 16, 1998
Do
Do
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications—Draft
October 26, 2000
Do
Do
Therapeutic Equivalence Code Placement on Prescription Drug Labels and Labeling—Draft
January 28, 1999
Do
Do
Acetaminophen and Codeine Phosphate Tablets/Capsules
December 1, 1993
Labeling
Do
Acetaminophen and Codeine Phosphate Oral Solution/Suspension
December 1, 1993
Do
Do
Acetaminophen, Aspirin and Codeine Phosphate Tablets/Capsules
December 1, 1993
Do
Do
Alprazolam Tablets USP
August 1, 1996
Do
Do
Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP
September 1, 1997
Do
Do
Amlodipine Besylate Tablets
September 1, 1997
Do
Do
Astemizole Tablets
September 1, 1997
Do
Do
Atenolol Tablets USP
August 1, 1997
Do
Do
Barbiturate, Single Entity-Class Labeling
March 1, 1981
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Butalbital, Acetaminophen and Caffeine Capsules/Tablets USP
September 1, 1997
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Butalbital, Acetaminophen, Caffeine and Hydocodone Bitartrate Tablets
September 21, 1997
Do
Do
Butorphanol Tartrate Injection USP
October 1, 1992
Do
Do
Captopril and Hydrochlorothiazide Tablets USP
April 1, 1995
Do
Do
Captopril Tablets
February 1, 1995
Do
Do
Carbidopa and Levodopa Tablets USP
February 1, 1992
Do
Do
Chlordiazepoxide Hydrochloride Capsules
January 1, 1988
Do
Do
Cimetidine Hydrochloride Injection
September 1, 1995
Do
Do
Cimetidine Tablets
September 1, 1995
Do
Do
Cisapride Oral Suspension
September 1, 1997
Do
Do
Cisapride Tablets
September 1, 1997
Do
Do
Clindamycin Phosphate Injection USP
September 1, 1998
Do
Do
Clorazepate Dipotassium Capsules/Tablets
March 1, 1993
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Combination Oral Contraceptives—Physician and Patient Labeling
January 1, 1994
Do
Do
Cyproheptadine Hydrochloride Tablets/Syrup
December 1, 1986
Do
Do
Diclofenac Sodium Delayed-Release Tablets
January 1, 1997
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Diltiazem Hydrochloride Extended-Release Capsules
September 1, 1995
Do
Do
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP
April 1, 1995
Do
Do
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP
April 1, 1995
Do
Do
Dipivefrin Hydrochloride Ophthalmic Solution, 0.1%
November 2, 1998
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Ergoloid Mesylates Tablets
January 1, 1988
Do
Do
Fludeoxyglucose F18 Injection
January 1, 1997
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Flurbiprofen Tablets USP
January 1, 1994
Do
Do
Fluvoxamine Maleate Tablets
September 1, 1997
Do
Do
Gentamicin Sulfate Ophthalmic Ointment and Solution USP
April 1, 1992
Do
Do
Heparin Sodium Injection USP
March 1, 1991
Do
Do
Hydrocodone Bitartrate and Acetaminophen Tablets USP
April 1, 1994
Do
Do
Hydroxyzine Hydrochloride Injection
December 1, 1989
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Hypoglycemic Oral Agents Federal Register
April 1, 1984
Do
Do
Indomethacin Capsules USP
September 1, 1995
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Informal Labeling Guidance Texts for Estrogen Drug Products Patient Labeling
August 1, 1992
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Informal Labeling Guidance Texts for Estrogen Drug Products: Professional Labeling
August 1, 1992
Do
Do
Isoetharine Inhalation Solution
March 1, 1989
Do
Do
Itraconazole Capsules, USP
September 1, 1998
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Leucovorin Calcium for Injection
July 1, 1996
Do
Do
Leucovorin Calcium Tablets, USP
July 1, 1996
Do
Do
Local Anesthetics Class Labeling
September 1, 1982
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Meclofenamate Sodium Capsules
July 1, 1992
Do
Do
Medroxyprogesterone Acetate Tablets, USP
September 1, 1998
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Metaproterenol Sulfate Inhalation Solution USP
May 1, 1992
Do
Do
Metaproterenol Sulfate Syrup USP
May 1, 1992
Do
Do
Metaproterenol Sulfate Tablets
May 1, 1992
Do
Do
Metoclopramide Tablets USP/Oral Solution
February 1, 1995
Do
Do
Naphazoline Hydrochloride Ophthalmic Solution
March 1, 1989
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Naproxen Sodium Tablets, USP
September 1, 1997
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Naproxen Tablets, USP
September 1, 1997
Do
Do
Niacin Tablets
July 1, 1982
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Paclitaxel Injection
September 1, 1997
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Phendimetrazine Tartrate Capsules/T Nets, and Extended-Release Capsules
February 1, 1991
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Phentermine Hydrochloride Capsules/Tablets
August 1, 1988
Do
Do
Promethazine Hydrochloride Tablets
March 1, 1990
Do
Do
Propantheline Bromide Tablets
August 1, 1988
Do
Do
Pyridoxine Hydrochloride Injection
June 1, 1984
Do
Do
Quinidine Sulfate Tablets/Capsules USP
October 1, 1995
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Ranitidine Tablets USP
November 1, 1993
Do
Do
Risperidone Oral Solution
September 1, 1997
Do
Do
Risperidone Tablets
September 1, 1997
Do
Do
Sulfacetainide Sodium and Prednisolone Acetate Ophthalmic Suspension and Ointment
January 1, 1995
Do
Do
Sulfacetamide Sodium Ophthalmic Solution/Ointment
August 1, 1992
Do
Do
Sulfamethoxazole and Phenazopyridine Hydrochloride Tablets
February 1, 1992
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Sulfamethoxazole and Trimethoprim Tablets and Oral Suspension
August 1, 1993
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Theophylline Immediate-Release Dosage Forms
February 1, 1995
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Theophylline Intravenous Dosage Forms
September 1, 1995
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Thiamine Hydrochloride Injection
February 1, 1988
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Tobramycin Sulfate Injection USP
May 1, 1993
Do
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Venlafaxine Hydrochloride Tablets
October 1, 1997
Do
Do
Verapamil Hydrochloride Tablets
October 1, 1991
Do
Do
Vitamin A Capsules
February 1, 1992
Do
Do
Zolpidem Tartrate Tablets
September 1, 1997
Do
Do
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products
April 1, 1996
Microbiology
Do
Labeling OTC Human Drug Products—Submitting Requests for Exemptions and Deferrals—Draft
December 19, 2000
OTC Draft
Do
Labeling OTC Human Drug Products: Updating Labeling in ANDAs—Draft
February 22, 2001
Do
Do
OTC Actual Use Studies—Draft
July 22, 1994
Do
Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
OTC Nicotine Substitutes—Draft
March 1, 1994
Do
Do
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)
OTC
http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
General Guidelines for OTC Combination Products
Do
Do
Labeling OCT Human Drug Products Using a Column Format
December 19, 2000
Do
Do
Upgrading Category III Antiperspirants to Category 1 (43 FR 46728-46731)
Do
Do
Carcinogenicity Study Protocol Submissions—Draft
November 7, 2000
Pharmacology/Toxicology Draft
Do
Immunotoxicology Evaluation of Investigational New Drugs—Draft
May 11, 2001
Do
Do
Photosafety Testing—Draft
January 10, 2000
Do
Do
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals—Draft
May 8, 2001
Do
Do
Content and Format of INDs for Phase 1 Studies of Drugs Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
October 4, 2000
Pharmacology/Toxicology
Do
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application
February 1, 1987
Do
Do
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
October 16, 1996
Do
Do
Reference Guide for the Nonclinical Toxicity Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies
February 1, 1989
Do
Do
Single Dose Acute Toxicity Testing Toxicity Testing for Pharmaceuticals
August 26, 1996
Do
Do
Applications Covered by Section 505(b)(2)—Draft
December 8, 1999
Procedural Draft
Do
Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products—Draft
March 10, 2000
Do
Do
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 CDER, Beginning January 1, 2000—Draft
December 22, 1999
Do
Do
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution—Draft
May 15, 2001
Do
Do
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank—Draft
March 29, 2000
Do
Do
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan—Draft
July 9, 2001
Do
Do
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act—Draft
August 17, 1999
Do
Do
PET Drug Applications—Content and Format for NDAs and ANDAs—Draft
March 10, 2000
Do
Do
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines—Draft
March 12, 2001
Do
Do
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies—Draft
January 4, 2001
Do
Do
Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997—Draft
April 4, 2001
Do
Do
Special Protocol Assessment—Draft
February 9, 2000
Do
Do
Submitting Debarment Certification Statements—Draft
October 2, 1998
Do
Do
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
July 14, 1998
Procedural
Do
Advisory Committees: Implementing Section 120 of the Food and Drug Modernization Act of 1997
November 2, 1998
Do
Do
Court Decisions, ANDA Approvals, and 130-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
March 30, 2000
Do
Do
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
November 30, 1999
Do
Do
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act
November 23, 1998
Do
Do
Fast Track Drug Development Programs: Designation, Development, and Application Review
November 18, 1998
Do
Do
Financial Disclosure by Clinical Investigators
March 20, 2001
Do
Do
Formal Dispute Resolution: Appeals Above the Division Level
March 7, 2000
Do
Do
Formal Meetings With Sponsors and Applicants for PDUFA Products
March 7, 2000
Do
Do
Implementation of Section 120 of the FDA Modernization Act of 1997—Advisory Committees
November 20, 1998
Do
Do
Implementation of Section 126 of the FDA Modernization Act of 1997—Elimination of Certain Labeling Requirements
July 21, 1998
Do
Do
Levothyroxine Sodium Products—Enforcement of August 14, 2001, Compliance Date and Submission of New Applications
July 13, 2001
Do
Do
National Uniformity for Nonprescription Drugs Ingredient Labeling for OTC Drugs
April 9, 1998
Do
Do
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act—Revised
October 1, 1999
Do
Do
Reduction of Civil Money Penalties for Small Business Entities
March 20, 2001
Do
Do
Refusal to File
July 12, 1993
Do
Do
Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act
June 15, 1998
Do
Do
Standards for the Prompt Review of Efficacy Supplements Including Priority Efficacy Supplements
May 15, 1998
Do
Do
Women and Minorities Guidance Requirements
July 20, 1998
Do
Do
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act
August 17, 1999
User Fee Draft
Do
Submitting Separate Marketing Applications and Definitions of Clinical Data for Purposes of Assessing User Fees—Draft
February 22, 2001
Do
Do
Waivers of and Reductions in User Fees (Attachment G)—Draft
July 16, 1993
Do
Do
Applicability of User Fees to: (1) Applications Withdrawn Before Filing Decision, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest (Attachment F)
July 12, 1993
User Fee
Do
Application, Product, and Establishment Fees: Common Issues and Their Resolution (Attachment D)
December 16, 1994
Do
Do
Classifying Resubmissions in Response to Action Letters
May 14, 1998
Do
Do
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act
August 25, 1999
Do
Do
Formal Meetings With Sponsors and Applicants for PDUFA Products
March 7, 2000
Do
Do
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)
October 26, 2000
Do
Do
Withdrawals
Name of Document
Date of Issuance
Intended User or Regulatory Activity
Date of Withdrawal
Dissemination and Reprints of Certain Published Original Data (No Replacement)
October 8, 1996
Advertising
February 16, 2000
Funded Dissemination of Reference Texts (No Replacement)
October 8, 1996
Advertising
February 16, 2000
Buspirone Hydrochloride Tablets In Vivo Bioequivalence (No Replacement)
May 14, 1998
Biopharmaceutics
November 30, 2000
Cimetidine Tablets In Vivo Bioequivalence and In Vitro Dissolution (No Replacement)
Unknown
Biopharmaceutics
November 30, 2000
Diclofenac Sodium (Tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing (No Replacement)
October 6, 1994
Biopharmaceutics
November 30, 2000
Glipizide In Vivo Bioequivalence and In Vivo Dissolution Testing (No Replacement)
Unknown
Biopharmaceutics
November 30, 2000
Glyburide In Vivo Bioequivalence and In Vivo Dissolution Testing (No Replacement)
Unknown
Biopharmaceutics
November 30, 2000
Oral Extended (Controlled) Release Dosage Forms In Vivo Bioequivalence and In Vitro Dissolution Testing (No Replacement)
Unknown
Biopharmaceutics
November 30, 2000
Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design (No Replacement)
July 1, 1992
Biopharmaceutics
November 30, 2000
Clinical Evaluation of Drugs to Prevent Dental Caries (No Replacement)
November 1, 1978
Clinical Medical
May 18, 2000
Clinical Evaluation of Drugs to Prevent, Control, and/or Treat Periodontal Disease (No Replacement)
November 1, 1978
Clinical Medical
May 18, 2000
OTC Treatment of Hypercholesterolemia (No Replacement)
October 27, 1997
OTC
August 3, 2000
Levothyroxine Sodium: Questions and Answers (Replaced by Levothyroxine Sodium Products Enforcement of August 14, 2001, Compliance Date and Submission of New Applications issued on July 13, 2001)
March 8, 2001
Procedural
July 13, 2001
IV. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
Name of Document
Date of Issuance
Intended User or Regulatory Activity
How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
FOD No.
The FDA Export Reform and Enhancement Act of 1996/Export Certification Package Including “Instructions for Requests for Certificate to Foreign Governments”
February 7, 2000
Office of Compliance (OC)
Division of Small Manufacturers Assistance; 1-800-638-2041 or 301-827-0111 or (FAX) Facts-on-Demand (FOD) at 1-800-899-0381 or Internet at http://www.fda.gov/ cdrh/ggpmain.html
865
Commercial Distribution/Exhibit Letter
April 10, 1992
OC
Do
246
Color Additive Status List (Inspection Operations Manual)
February 1, 1989
OC
Do
268
FDA Guide for Validation of Biological Indicator Incubation Time
January 1, 1986
OC
Do
283
Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)
March 1, 1988
OC
Do
286
Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236)
September 1, 1989
OC
Do
295
Color Additive Petitions (p. 11-19 of PMA Manual)
June 1, 1987
OC
Do
296
Guidance for Preparation of PMA Manufacturing Information
August 1, 1992
OC
Do
448
Civil Money Penalty Policy; Guidance for FDA Staff
June 8, 1999
OC
Do
1124
General Principles of Software Validation; Draft Guidance
June 9, 1997
OC
Do
938
Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub. No. 95-4246)
March 1, 1995
OC
Do
10
Cover Letter/Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cable
March 9, 1998
OC
Do
1197
Guidance on Medical Device Tracking [FDAMA]; Guidance for Industry and FDA Staff
January 24, 2000
OC
Do
169
Compliance Program Guidance Manual: Inspection of Medical Devices; Draft
August 12, 1999
OC
Do
1702
Procedures for Laboratory Compliance Testing of Television Receivers—Part of TV Packet
May 1, 1986
OC
Do
945
Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [510(k)] [CPG 7124.19]
September 24, 1987
OC
Do
181
Letter to Medical Device Manufacturer on Pentium Processors
February 14, 1995
OC
Do
456
Implementation of the Biomaterials Access Assurance Act of 1998
April 2, 2001
OC
Do
1324
Guideline for the Monitoring of Clinical Investigations
January 1, 1988
OC
Do
428
Regulating In Vitro Diagnostic Device (IVD) Studies; Guidance for FDA Staff
December 17, 1999
OC/Division of Bioresearch Monitoring (DBM)
Do
1132
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects
March 19, 1999
OC/DBM
Do
2229
Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables
November 15, 1999
OC/Division of Enforcement (DOE) I
Do
1129
Guidance on Quality System Regulation Information for Various Premarket Submissions; Draft
August 3, 1999
OC/DOEII
Do
1140
Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves; Guidance for Industry—Draft
July 26, 2000
OC/DOEII
Do
1141
Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)
October 13, 1993
OC/DOEI
Do
116
Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components
January 1, 1982
OC/DOEI
Do
257
Exemption From Reporting and Recordkeeping Requirements for Certain Sunlamp Product Manufacturers
September 16, 1981
OC/DOEI
Do
343
Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi)
May 17, 1993
OC/DOEI
Do
545
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)
March 1, 1989
OC/DOEI
Do
758
CPG 7133.19: Retention of Microwave Oven Test Record/Cover Letter: 08/24, 1981 Retention of Records Required by 21 CFR [Part] 1002
March 1, 1995
OC/DOEI
Do
880
Guideline for the Manufacture of In Vitro Diagnostic Products
January 10, 1994
OC/DOEI
Do
918
A Guide for the Submission of Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting Device
March 1, 1996
OC/DOEI
Do
977
A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use
March 1, 1996
OC/DOEI
Do
978
A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems
March 1, 1996
OC/DOEI
Do
979
Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff
March 15, 2000
OC/DOEI
Do
1133
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA
April 2, 2001
OC/DOEI
Do
2619
Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10
April 1, 1971
OC/DOEI&III
Do
235
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
August 1, 1995
OC/DOEI&III
Do
236
Guide for Preparing Reports on Radiation Safety of Microwave Ovens
March 1, 1985
OC/DOEI&III
Do
239
Reporting Guide for Laser Light Shows and Displays (21 CFR [Part] 1002) (FDA 88-8140)
September 1, 1995
OC/DOEI&III
Do
251
Guide for Filing Annual Reports for X-Ray Components and Systems
July 1, 1980
OC/DOEI&III
Do
253
Reporting and Compliance Guide for Television Products Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance
October 1, 1995
OC/DOEI&III
Do
260
Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (Replaces FDA 82-8127)
September 1, 1995
OC/DOEI&III
Do
264
Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use
September 1, 1996
OC/DOEI&III
Do
399
Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service Manuals
October 31, 1988
OC/DOEI&III
Do
697
Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic Products
August 1, 1995
OC/DOEI&III
Do
951
Guide for Preparing Product Reports for Medical Ultrasound Products
September 1, 1996
OC/DOEI&III
Do
960
Letter—Manufacturers, Distributors and Importers of Condom Products
February 23, 1994
OC/DOEII
Do
52
Letter—Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)
February 13, 1989
OC/DOEII
Do
53
Letter—Condom Manufacturers and Distributors
April 5, 1994
OC/DOEII
Do
56
Letter to Manufacturers/Repackers Using Cotton
April 22, 1994
OC/DOEII
Do
101
Guide for Preparing Product Reports for Lasers and Products Containing Lasers
September 1, 1995
OC/DOEII
Do
277
Compliance Guide for Laser Products (FDA 86-8260)
September 1, 1985
OC/DOEII
Do
278
Condoms: Inspection and Sampling at Domestic Manufacturers and of All Repackers; Sampling From All Importers (Damaska Memo to Field on 4/8, 1987)
April 8, 1987
OC/DOEII
Do
293
Dental Handpiece Sterilization (Dear Doctor Letter)
September 28, 1992
OC/DOEII
Do
589
Latex Labeling Letter (Johnson)
March 18, 1993
OC/DOEII
Do
831
Pesticide Regulation Notice 94-4: Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides With Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA
June 30, 1994
OC/DOEII
Do
851
Letter to Industry, Powered Wheelchair Manufacturers From RM Johnson
May 10, 1993
OC/DOEII
Do
869
Hazards of Volume Ventilators and Heated Humidifiers
September 15, 1993
OC/DOEII
Do
901
Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals
February 3, 1994
OC/DOEII
Do
933
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure
June 23, 1978
OC/DOEII
Do
1019
Letter to: Manufacturers and Users of Lasers for Refractive Surgery [Excimer]
October 10, 1996
OC/DOEII
Do
1093
Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy
August 23, 1996
OC/DOEII
Do
1122
Surveillance and Detention Without Physical Examination of Condoms; Guidance for Industry; Draft
August 14, 2000
OC/DOEII
Do
1139
All U.S. Condom Manufacturers, Importers and Repackagers
April 7, 1987
OC/DOEII
Do
2510
Manufacturers and Initial Distributors of Hemodialyzers
May 23, 1996
OC/DOEII
Do
2507
Laser Light Show Safety—Who's Responsible? (FDA 86-8262)
May 1, 1986
OC/DOEIII
Do
13
Suggested State Regulations for Control of Radiation—Volume II Nonionizing Radiation—Lasers (FDA Pub. No. 83-8220)
January 1, 1982
OC/DOEIII
Do
70
Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards Exist
May 28, 1981
OC/DOEIII
Do
231
Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10
March 1, 1973
OC/DOEIII
Do
237
Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10
April 30, 1974
OC/DOEIII
Do
240
Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40
February 1, 1975
OC/DOEIII
Do
241
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)
October 1, 1987
OC/DOEIII
Do
243
Computerized Devices/Processes Guidance—Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes
May 1, 1992
OC/DOEIII
Do
247
Guide for Preparing Product Reports for Ultrasonic Therapy Products (Physical Therapy Only)
August 1, 1996
OC/DOEIII
Do
249
Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)
September 1, 1980
OC/DOEIII
Do
254
Guide for Preparing Annual Reports for Ultrasonic Therapy Products
September 1, 1996
OC/DOEIII
Do
261
Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (Replaces FDA 82-8127)
September 1, 1995
OC/DOEIII
Do
262
Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (Replaces FDA 82-8127)
September 1, 1995
OC/DOEIII
Do
263
Quality Control Guide for Sunlamp Products (FDA 88-8234)
March 1, 1988
OC/DOEIII
Do
270
Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems
September 1, 1984
OC/DOEIII
Do
271
Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR [Part] 1002)
September 1, 1995
OC/DOEIII
Do
279
Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products
August 21, 1986
OC/DOEIII
Do
342
Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR [Part] 1002)
September 1, 1995
OC/DOEIII
Do
348
Quality Control Practices for Compliance With the Federal Mercury Vapor Lamp Performance Standard
May 1, 1980
OC/DOEIII
Do
349
Keeping Up With the Microwave Revolution (FDA Pub. No. 91-4160)
March 1, 1990
OC/DOEIII
Do
356
Quality Assurance Guidelines for Hemodialysis Devices
February 1, 1991
OC/DOEIII
Do
507
Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven Miswiring
March 28, 1980
OC/DOEIII
Do
646
Reporting of New Model Numbers to Existing Model Families
June 14, 1983
OC/DOEIII
Do
675
Import: Radiation-Producing Electronic Products (FDA 89-8008)
November 1, 1988
OC/DOEIII
Do
756
Unsafe Patient Lead Wires and Cables
September 3, 1993
OC/DOEIII
Do
889
Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device [Form FDA 3147]
July 1, 1998
OC/DOEIII
Do
903
Letter to Trade Association: Reuse of Single-Use or Disposable Medical Devices
December 27, 1995
OC/DOEIII
Do
961
Design Control Guidance for Medical Device Manufacturers
March 11, 1997
OC/DOEIII
Do
994
Keeping Medical Devices Safe From Electromagnetic Interference
July 1, 1995
OC/DOEIII
Do
1081
Medical Devices and EMI: The FDA Perspective
January 1, 1995
OC/DOEIII
Do
1082
Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations
OC/DOEIII
Do
1086
Safety of Electrically Powered Products: Letter to Medical Device and Electronic Product Manufacturers From Lillian Gill and BHB Correction Memo
September 18, 1996
OC/DOEIII
Do
1087
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff
August 14, 2000
OC/DOEIII
Do
1168
Labeling for Electronic Anti-Theft Systems; Guidance for Industry; Final
August 15, 2000
OC/DOEIII
Do
1170
Wireless Medical Telemetry Risks and Recommendations, Guidance for Industry; Final
September 27, 2000
OC/DOEIII
Do
1173
Policy on Warning Label Required on Sunlamp Products
June 25, 1985
OC/DOEIII
Do
1343
Policy on Lamp Compatibility (Sunlamps)
September 2, 1986
OC/DOEIII
Do
2343
Guidance for Industry on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
August 5, 1999
OC/Division of Program Operations (DPO)
Do
1269
Guidance on IDE Policies and Procedures [FDAMA]; Final
January 20, 1998
Office of Device Evaluation (ODE)
Do
882
Color Additives for Medical Devices
November 15, 1995
ODE
Do
575
Preamendment Class III Devices
March 11, 1992
ODE
Do
584
Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size Distribution
Date not available
ODE
Do
595
Guidance for Submitting Reclassification Petition
June 1, 1989
ODE
Do
609
Electromagnetic Compatibility for Medical Devices: Issues and Solutions; Memorandum
June 13, 1995
ODE
Do
639
SMDA Changes—Premarket Notification; Regulatory Requirements for Medical Devices [510(k)] Manual Insert
April 17, 1992
ODE
Do
655
“Real-Time” Review Program for Premarket Approval Application (PMA) Supplements
April 22, 1997
ODE
Do
673
Classified Convenience Kits
April 30, 1993
ODE
Do
789
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; Final
February 19, 1998
ODE
Do
795
Suggested Content for Original IDE Application Cover Letter—Version 4
February 27, 1996
ODE
Do
797
Device Specific Guidance Documents (List)
May 11, 1993
ODE
Do
815
PMA Shell Development and Modular Review; Guidances for the Medical Device Industry; Final
November 6, 1998
ODE
Do
835
Determination of Intended Use for 510(k) Devices—Guidance for Industry and CDRH Staff [FDAMA]; Final
January 30, 1998
ODE
Do
857
Premarket Notification [510(k)] Status Request Form, Revised
March 14, 1997
ODE
Do
858
CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File Policies
June 30, 1993
ODE
Do
859
Indications for Use Statement
February 6, 1996
ODE
Do
879
The New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Final
March 20, 1998
ODE
Do
905
Preamendments Class III Strategy; SXAlpert
April 19, 1994
ODE
Do
611
Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer From Susan Alpert, Ph.D., M.D.
May 26, 1994
ODE
Do
883
ODE Executive Secretary Guidance Manual
August 7, 1987
ODE
Do
1338
Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; Guidance for Industry; Draft
August 6, 1998
ODE
Do
102
CDRH Submissions Coversheet [PMA/PDP/510k/IDE]
May 8, 1998
ODE
Do
147
Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff [FDAMA]; Final
February 19, 1998
ODE
Do
159
Limulus Amebocyte Lysate; Reduction of Samples for Testing
October 23, 1987
ODE
Do
178
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance
April 1, 1996
ODE
Do
198
New Section 513(f)(2)—Evaluation of Automatic Class III Designation; Guidance for Industry and CDRH Staff [FDAMA]; Final
February 19, 1998
ODE
Do
199
Methods for Conducting Recall Effectiveness Checks
June 16, 1978
ODE
Do
225
Suggestions for Submitting a Premarket Approval (PMA) Application
April 1, 1993
ODE
Do
228
Guidance for Off-the-Shelf Software Use in Medical Devices; Final
September 9, 1999
ODE
Do
1252
Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices
December 1, 1983
ODE
Do
267
Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products (From John C. Petricciani, M.D.)
June 1, 1984
ODE
Do
269
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA]
February 19, 1998
ODE
Do
310
Format for IDE Progress Reports
June 1, 1996
ODE
Do
311
Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—For Use by CDRH and Industry [FDAMA]; Final
February 19, 1998
ODE
Do
322
Industry Representatives on Scientific Panels
March 27, 1987
ODE
Do
329
PMA Review Schedule [P87-1]
March 31, 1988
ODE
Do
333
Necessary Information for Diagnostic Ultrasound 510(k) (Draft)
November 24, 1987
ODE
Do
335
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; Final
May 29, 1998
ODE
Do
337
Master Files Part III; Guidance on Scientific and Technical Information
June 1, 1987
ODE
Do
338
510(k) Quality Review Program (Blue Book Memo) (I96-1)
March 29, 1996
ODE
Do
344
FDA Policy for the Regulation of Computer Products (Draft)
November 13, 1989
ODE
Do
351
Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976
January 1, 1990
ODE
Do
352
4-of-A-Kind PMAs
October 1, 1991
ODE
Do
371
Supplements to Approved Applications for Class III Medical Devices: Use Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; Final
May 20, 1998
ODE
Do
380
Substantial Equivalence (SE) Decision Making Documentation ATTACHED: “SE” Decision Making Process (Detailed), i.e., the Decision Making Tree
January 1, 1990
ODE
Do
390
Shelf Life of Medical Devices
March 1, 1991
ODE
Do
415
Guideline on General Principles of Process Validation
May 1, 1987
ODE
Do
425
Guideline on Sterile Drug Products Produced by Aseptic Processing
June 1, 1987
ODE
Do
426
Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test
December 1, 1987
ODE
Do
427
General/Specific Intended Use [FDAMA]; Draft Guidance for Industry
November 4, 1998
ODE
Do
499
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo
#
P98-1]; Final
October 10, 1997
ODE
Do
563
Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated 6/25, 1993, Device “Fast Track” Plan Announcement (Include with 926-930)
June 30, 1993
ODE
Do
931
New Model Medical Device Development Process; Guidance for Industry; Final
July 21, 1998
ODE
Do
1101
Guidance on the Use of Standards in Substantial Equivalence Determinations; Final
March 12, 2000
ODE
Do
1131
Guidance for Industry and for FDA Reviewers; Interpretive Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997
August 9, 2000
ODE
Do
1135
Evidence Models for the Least Burdensome Means to Market; Guidance for Industry and FDA Reviewers; Draft
September 1, 1999
ODE
Do
1154
Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
September 3, 1996
ODE
Do
1198
Deciding When to Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry
November 30, 2000
ODE
Do
1073
Guidance on Amended Procedures for Advisory Panel Meetings
July 22, 2000
ODE
Do
413
Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final
November 16, 1998
ODE
Do
2206
Frequently Asked Questions on the New 510(k) Paradigm; Guidance for Industry; Final
October 22, 1998
ODE
Do
2230
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Draft Guidance for FDA and Industry
May 3, 2001
ODE
Do
1332
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters
September 12, 1994
ODE Division of Reproductive, Abdominal, and Radiological Devices (DRARD)
Do
97
Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastroenterology and Urology
November 1, 1994
ODE/DRARD
Do
98
Convenience Kits Interim Regulatory Guidance (Include 874)
May 20, 1997
ODE/510K
Do
562
Announcement: Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Categorization of Investigational Devices
#
D95-2 (Blue Book Memo)
September 15, 1995
ODE/BlueBook
Do
106
Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices
#
G90-2 (Blue Book Memo)
October 19, 1990
ODE/BlueBook
Do
30
Consolidated Review of Submissions for Lasers and Accessories
#
G90-1 (Blue Book Memo)
October 19, 1990
ODE/BlueBook
Do
31
Review of Final Draft Medical Device Labeling
#
P91-4 (Blue Book Memo)
August 29, 1991
ODE/BlueBook
Do
34
Review of 510(k)s for Computer Controlled Medical Devices
#
K91-1 (Blue Book Memo)
August 29, 1991
ODE/BlueBook
Do
35
Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” (Replaces
#
G87-1
#
8294) (Blue Book Memo)
May 1, 1995
ODE/BlueBook
Do
164
ODE Regulatory Information for the Office of Compliance—Information Sharing Procedures
#
G87-2 (Blue Book Memo)
May 15, 1987
ODE/BlueBook
Do
276
Panel Review of “Me-Too” Devices
#
P86-6 (Blue Book Memo)
July 1, 1986
ODE/BlueBook
Do
280
Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program
#
K86-3 (Blue Book Memo)
June 30, 1986
ODE/BlueBook
Do
289
PMA Filing Decisions
#
P90-2 (Blue Book Memo)
May 18, 1990
ODE/BlueBook
Do
297
PMAs—Early Review and Preparation of Summaries of Safety and Effectiveness
#
P86-1 (Blue Book Memo)
January 27, 1986
ODE/BlueBook
Do
302
Criteria for Panel Review of PMA Supplements
#
P86-3 (Blue Book Memo)
January 30, 1986
ODE/BlueBook
Do
304
Review and Approval of PMAs of Licensees
#
P86-4 (Blue Book Memo)
October 22, 1990
ODE/BlueBook
Do
305
Panel Report and Recommendations on PMA Approvals
#
P86-5 (Blue Book Memo)
April 18, 1986
ODE/BlueBook
Do
306
510(k) Sign-Off Procedures
#
K94-2 (Blue Book Memo)
June 3, 1994
ODE/BlueBook
Do
308
Review of Laser Submissions
#
G88-1 (Blue Book Memo)
April 15, 1988
ODE/BlueBook
Do
330
Delegation of IDE Actions
#
D88-1 (Blue Book Memo)
April 26, 1988
ODE/BlueBook
Do
331
Premarket Notification—Consistency of Reviews
#
K89-1 (Blue Book Memo)
February 28, 1989
ODE/BlueBook
Do
339
Telephone Communications Between ODE Staff and Manufacturers
#
I93-1 (Blue Book Memo)
January 29, 1993
ODE/BlueBook
Do
360
510(k) Sterility Review Guidance—and Revision of 11/18/1994
#
K90-1 (Blue Book Memo)
February 12, 1990
ODE/BlueBook
Do
361
Review of IDEs for Feasibility Studies
#
D89-1 (Blue Book Memo)
May 17, 1989
ODE/BlueBook
Do
362
Toxicology Risk Assessment Committee
#
G89-1 (Blue Book Memo)
August 9, 1989
ODE/BlueBook
Do
363
Assignment of Review Documents
#
I90-2 (Blue Book Memo)
August 24, 1990
ODE/BlueBook
Do
366
Meetings With the Regulated Industry
#
I89-3 (Blue Book Memo)
November 20, 1989
ODE/BlueBook
Do
367
Policy Development and Review Procedures
#
I90-1 (Blue Book Memo)
February 15, 1990
ODE/BlueBook
Do
368
PMA Supplements: ODE Letter to Manufacturers; Identifies Situations Which May Require the Submission of a PMA Supplement (When PMA Supplements Are Required)
#
P90-1 (Blue Book Memo)
April 24, 1990
ODE/BlueBook
Do
387
510(k) Refuse to Accept Procedures
#
K94-1 (Blue Book Memo)
May 20, 1994
ODE/BlueBook
Do
401
PMA Refuse to File Procedures
#
P94-1 (Blue Book Memo)
May 20, 1994
ODE/BlueBook
Do
402
Premarket Approval Application (PMA) Closure
#
P94-2 (Blue Book Memo)
July 8, 1994
ODE/BlueBook
Do
403
PMA/510(k) Triage Review Procedures
#
G94-1 (Blue Book Memo)
May 20, 1994
ODE/BlueBook
Do
404
Goals and Initiatives for the IDE Program
#
D95-1 (Blue Book Memo)
July 12, 1995
ODE/BlueBook
Do
405
Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (Blue Book Memo
#
K95-1)
November 21, 1995
ODE/BlueBook
Do
406
IDE Refuse to Accept Procedures
#
D94-1 (Blue Book Memo)
May 20, 1994
ODE/BlueBook
Do
410
Device Labeling Guidance
#
G91-1 (Blue Book Memo)
March 8, 1991
ODE/BlueBook
Do
414
Clinical Utility and Premarket Approval
#
P91-1 (Blue Book Memo)
May 3, 1991
ODE/BlueBook
Do
443
Panel Review of Premarket Approval Applications
#
P91-2 (Blue Book Memo)
May 3, 1991
ODE/BlueBook
Do
444
PMA Compliance Program
#
P91-3 (Blue Book Memo)
May 3, 1991
ODE/BlueBook
Do
445
Document Review Processing
#
I91-1 (Blue Book Memo)
February 12, 1992
ODE/BlueBook
Do
446
Integrity of Data and Information Submitted to ODE
#
I91-2 (Blue Book Memo)
May 29, 1991
ODE/BlueBook
Do
447
Nondisclosure of Financially Sensitive Information
#
I92-1 (Blue Book Memo)
March 5, 1992
ODE/BlueBook
Do
587
Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo
#
G96-3))
August 9, 1996
ODE/BlueBook
Do
806
Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1)
July 15, 1996
ODE/BlueBook
Do
872
510(k) Additional Information Procedures
#
K93-1 (Blue Book Memo)
July 23, 1993
ODE/BlueBook
Do
886
Overdue IDE Annual Progress Report Procedures
#
D93-1 (Blue Book Memo)
July 23, 1993
ODE/BlueBook
Do
887
Documentation and Resolution of Differences of Opinion on Product Evaluations
#
G93-1 (Blue Book Memo)
December 23, 1993
ODE/BlueBook
Do
920
Deciding When to Submit a 510(k) for a Change to an Exisiting Device; (Blue Book Memo
#
K97-1)
January 10, 1997
ODE/BlueBook
Do
1935
Interagency Agreement Between FDA and HCFA;
#
D95-2, Attachment A
September 15, 1995
ODE/BlueBook
Do
2106
Executive Secretaries Guidance Manual
#
G87-3
August 7, 1987
ODE/BlueBook
Do
2326
Criteria for Categorization of Investigational Devices (HCFA);
#
D95-2, Attachment B
September 15, 1995
ODE/BlueBook
Do
3106
Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy—(Updated Checklist March 14, 1995)
June 30, 1993
ODE/BlueBook
Do
3859
HCFA Reimbursement Categorization Determinations for FDA-Approved IDEs
October 31, 1995
ODE/BlueBook
Do
4106
Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy
June 30, 1993
ODE/BlueBook
Do
4859
Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; Draft Guidance—Not for Implementation
November 14, 2000
ODE Division of Clinical Laboratory Devices (DCLD)
Do
152
Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies
August 31, 1995
ODE/DCLD
Do
1191
Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; Draft
December 21, 1999
ODE/DCLD
Do
1359
Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA)
February 1, 1994
ODE/DCLD
Do
51
Review Criteria for Blood Culture Systems
August 12, 1991
ODE/DCLD
Do
82
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
September 26, 1994
ODE/DCLD
Do
95
Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery
February 20, 1996
ODE/DCLD
Do
122
Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies; Draft
August 31, 1995
ODE/DCLD
Do
1191
Review Criteria for Assessment of Rheumatoid Factor (RF) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry
February 21, 1997
ODE/DCLD
Do
165
Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Points to Consider Regarding Labeling and Premarket Submissions; Draft
October 1, 1988
ODE/DCLD
Do
272
Guidance for Submission of Immunohistochemistry Applications to the FDA; Final
June 3, 1998
ODE/DCLD
Do
364
Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers
July 15, 1991
ODE/DCLD
Do
417
Review Criteria for Assessment of Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies
July 15, 1994
ODE/DCLD
Do
459
Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies; Draft
September 26, 1991
ODE/
Do
475
Points to Consider for Hematology Quality Control Materials
September 30, 1997
ODE/DCLD
Do
512
Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents
August 1, 1992
ODE/DCLD
Do
527
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March 14, 1996
February 1, 1996
ODE/DCLD
Do
553
Review Criteria for Devices Intended for the Detection of Hepatitis B “e” Antigen and Antibody to HBe
December 30, 1991
ODE/DCLD
Do
554
Guidance Criteria for Cyclosporine PMAs
January 24, 1992
ODE/DCLD
Do
564
Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter Pylori
September 17, 1992
ODE/DCLD
Do
588
Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
September 27, 1995
ODE/DCLD
Do
592
Premarketing Approval Review Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) With Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bi; Draft
September 10, 1992
ODE/DCLD
Do
603
Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology
February 14, 1996
ODE/DCLD
Do
604
Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home Use
July 14, 1995
ODE/DCLD
Do
605
Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases
May 31, 1990
ODE/DCLD
Do
629
Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; Draft
September 30, 1991
ODE/DCLD
Do
658
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19
May 15, 1992
ODE/DCLD
Do
770
Guidance Document for 510(k) Submission of Fecal Occult Blood Tests; Draft
July 29, 1992
ODE/DCLD
Do
772
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens
January 1, 1992
ODE/DCLD
Do
778
Guidance Document for 510(k) Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; Draft
September 1, 1992
ODE/DCLD
Do
785
Review Criteria for the Assessment of Allergen-Specific Immunoglobulin E (IGE) In Vitro Diagnostic Devices Using Immunological Test Methodologies
March 2, 1993
ODE/DCLD
Do
800
Review Criteria for the Assessment of Anti-Nuclear Antibodies (ANA) In Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA).
September 1, 1992
ODE/DCLD
Do
848
Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; Draft
June 14, 1993
ODE/DCLD
Do
861
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)]
July 6, 1993
ODE/DCLD
Do
862
Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers
June 10, 1996
ODE/DCLD
Do
950
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification [510(k)] to FDA
September 19, 1996
ODE/DCLD
Do
957
Points to Consider for Cervical Cytology Devices
July 25, 1994
ODE/DCLD
Do
968
Review Criteria for In Vitro Diagnostic Devices That Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)
February 15, 1996
ODE/DCLD
Do
980
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Guidance for Industry; Final
July 6, 1998
ODE/DCLD
Do
1102
In Vitro Diagnostic Chloride Test System; Guidance for Industry; Final
July 6, 1998
ODE/DCLD
Do
1103
In Vitro Diagnostic Creatinine Test System; Guidance for Industry; Final
July 2, 1998
ODE/DCLD
Do
1104
In Vitro Diagnostic Glucose Test System; Guidance for Industry; Final
July 6, 1998
ODE/DCLD
Do
1105
In Vitro Diagnostic Potassium Test System; Guidance for Industry; Final
July 6, 1998
ODE/DCLD
Do
1107
In Vitro Diagnostic Sodium Test System; Guidance for Industry; Final
July 6, 1998
ODE/DCLD
Do
1109
In Vitro Diagnostic Urea Nitrogen Test System; Guidance for Industry; Final
July 6, 1998
ODE/DCLD
Do
1110
Guidance for Administrative Procedures for CLIA Categorization; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; Draft
August 14, 2000
ODE/DCLD
Do
1143
Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA Applications
March 1, 2001
ODE/DCLD
Do
1147
Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)s
July 22, 2000
ODE/DCLD
Do
1171
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s
July 22, 2000
ODE/DCLD
Do
1172
Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; Draft
March 8, 2000
ODE/DCLD
Do
631
In Vitro Diagnostic C-Reactive Protein Immunological Test System; Guidance for Industry; Final
July 20, 1998
ODE/DCLD
Do
1246
Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Guidance for Industry: Final
February 22, 1999
ODE/DCLD
Do
1247
Guidance on Labeling for Laboratory Tests; Guidance for Industry; Draft
June 24, 1999
ODE/DCLD
Do
1352
Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That Are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Draft
October 8, 1999
ODE/DCLD
Do
1353
Class II Special Control Guidance Document for Anti-Saccharomyces Cerevisiae (S. Cerevisiae) Antibody (ASCA) Premarket Notifications; Final
August 23, 2000
ODE/DCLD
Do
1183
Guidance for Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final; Guidance for Industry and FDA
November 1, 2000
ODE/DCLD
Do
1184
Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs
October 30, 1996
ODE/DCLD
Do
1631
Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Guidance for Industry; Draft
November 14, 2000
ODE/DCLD
Do
2209
Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Guidance for Industry
February 3, 1999
ODE/DCLD
Do
2231
Document for Special Controls for Erythropoietin Assay Premarket Notifications [510(k)s]; Guidance for Industry; Final
April 28, 1999
ODE/DCLD
Do
2241
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Guidance for Industry and FDA Reviewers/Staff; Final
April 27, 1999
ODE/DCLD
Do
2242
Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers
November 30, 2000
ODE/DCLD
Do
1072
Guidance for Electrical Safety, Electromagnetic Compatibility and Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions
June 28, 2000
ODE Division of Cardiovascular and Respiratory Devices (DCRD)
Do
1161
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final
November 1, 2000
ODE/DCRD
Do
372
Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers
November 8, 2000
ODE/DCRD
Do
1199
Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final
November 1, 2000
ODE/DCRD
Do
1357
Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff
January 31, 2001
ODE/DCRD
Do
1358
1-Consolidated Annual Report for a Device Product Line (1-CARD); Pilot for Preparation of Annual Reports for Pacemaker Premarket Approval Applications
July 6, 2000
ODE/DCRD
Do
1167
Excerpts Related to EMI From November 1993 Anesthesiology and Respiratory Devices Branch (Including Electromagnetic Compatibility Standard for Medical Devices; 10/1/79)
November 1, 1993
ODE/DCRD
Do
638
Guidance for Infant/Child Apnea Monitor 510(k) Submissions
September 22, 2000
ODE/DCRD
Do
1178
Guidance for Industry and for FDA Reviewers: Recommended Clinical Study Design for Ventricular Tachycardia Ablation
May 7, 1999
ODE/DCRD
Do
2244
Guidance for Industry: Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Draft
August 25, 1999
ODE/DCRD
Do
266
Guidance for Cardiovascular Intravascular Filter 510(k) Submission; Final
November 26, 1999
ODE/DCRD
Do
24
Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Electrode—Version 1.0
February 11, 1997
ODE/DCRD
Do
25
Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Lead Switching Adapter—Version 1.0
February 11, 1997
ODE/DCRD
Do
26
Guidance Document Device: Electrocardiograph (ECG) Surface Electrode Tester—Version 1.0
February 11, 1997
ODE/DCRD
Do
27
Draft Guidance Outline—Points to Consider for Clinical Studies for Vasovasostomy Devices
November 30, 1993
ODE/DCRD
Do
100
Medical Device Labeling—Suggested Format and Content; Draft Document
April 25, 1997
ODE/DCRD
Do
119
Non-Invasive Blood Pressure (NIBP) Monitor Guidance
March 10, 1997
ODE/DCRD
Do
123
Policy for Expiration Dating (DCRD RB92-G)
October 30, 1992
ODE/DCRD
Do
137
Human Heart Valve Allografts; Draft
June 21, 1991
ODE/DCRD
Do
224
Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final
February 16, 2000
ODE/DCRD
Do
1632
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final
February 21, 2000
ODE/DCRD
Do
1622
Balloon Valvuloplasty Guidance for the Submission of an IDE Application and a PMA Application
January 1, 1989
ODE/DCRD
Do
370
Replacement Heart Valve Guidance; Draft
October 14, 1994
ODE/DCRD
Do
375
Implantable Pacemaker Testing Guidance
January 12, 1990
ODE/DCRD
Do
383
Letter/Guidance: Vascular Graft Manufacturer, Developer, or Representative
May 11, 1990
ODE/DCRD
Do
391
Reviewer Guidance for Ventilators; Draft
July 1, 1995
ODE/DCRD
Do
500
Draft 510(k) Checklist for Urological Irrigation System and Tubing Set
August 1, 1995
ODE/DCRD
Do
515
Draft Guidance to Firms on Biliary Lithotripsy Studies
August 2, 1990
ODE/DCRD
Do
522
Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
November 11, 1994
ODE/DCRD
Do
533
Letter: Notice to Manufacturers of Bone Mineral Densitometers
September 25, 1997
ODE/DCRD
Do
552
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Draft
September 30, 1997
ODE/DCRD
Do
560
Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters
January 24, 1992
ODE/DCRD
Do
567
Guideline for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age
May 1, 1990
ODE/DCRD
Do
577
Guidance for the Preparation of the Annual Report to the PMA Approved Heart Valve Prostheses
April 1, 1990
ODE/DCRD
Do
582
Draft Version: Electrode Recording Catheter Preliminary Guidance (Data to Be Sumitted to the FDA in Support of Premarket Notifications [510(k)s])
March 1, 1995
ODE/DCRD
Do
602
Cardiac Ablation Preliminary Guidance (Data to Be Submitted to the FDA in Support Investigation Device Exemption Application; Draft
March 1, 1995
ODE/DCRD
Do
619
Premarket Testing Guidelines for Falloposcopes
November 20, 1992
ODE/DCRD
Do
621
Guidelines for Evaluation of Non-Drug IUDs
September 28, 1976
ODE/DCRD
Do
641
Simplified 510(k) procedures for certain radiology devices: 12/21, 1993, letter from L Yin, ODE/ODE/DRARD, to NEMA
December 21, 1993
ODE/DCRD
Do
708
Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology
August 16, 1995
ODE/DCRD
Do
768
Heated Humidifier Review Guidance
August 30, 1991
ODE/DCRD
Do
780
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
October 1, 1993
ODE/DCRD
Do
784
Reviewer Guidance for Automatic X-Ray Film Processor 510(k)
February 1, 1990
ODE/DCRD
Do
788
Guidance for the Technical Content of a Premarket Approval (PMA) Application for an Endolymphatic Shunt Tube With Valve
April 1, 1990
ODE/DCRD
Do
791
Guidance for Magnetic Resonance Diagnostic Devices—Criteria for Significant Risk Investigations
September 29, 1997
ODE/DCRD
Do
793
Draft Guidance for Preparation of PMA Applications for Testicular Prostheses
March 16, 1993
ODE/DCRD
Do
809
Draft Guidance for Preparation of PMA Applications for Penile Inflatable Implants
March 16, 1993
ODE/DCRD
Do
810
Draft Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis
May 30, 1997
ODE/DCRD
Do
842
Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; Draft
May 1, 1995
ODE/DCRD
Do
846
Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence
November 29, 1995
ODE/DCRD
Do
850
Draft Guidance for Review of Bone Densitometer 510(k) Submissions
November 9, 1992
ODE/DCRD
Do
866
Battery Guidance
July 12, 1993
ODE/DCRD
Do
873
Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses; Draft
August 1, 1993
ODE/DCRD
Do
885
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments
September 19, 1994
ODE/DCRD
Do
892
Draft Guidance for Hemodialyzer Reuse Labeling
October 6, 1995
ODE/DCRD
Do
899
Hysteroscopes and Gynecology Laparoscopes—Submission Guidance for a 510(k)—Includes 00192
March 27, 1996
ODE/DCRD
Do
907
Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions
July 29, 1991
ODE/DCRD
Do
953
Intravascular Brachytherapy—Guidance for Data to be Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; Draft
May 24, 1996
ODE/DCRD
Do
955
Percutaneous Transluminal Coronary Angioplasty Package Insert Template; Draft
February 7, 1995
ODE/DCRD
Do
959
Coronary and Cerebrovascular Guidewire Guidance
January 1, 1995
ODE/DCRD
Do
964
Guidance for Implantable Cardioverter-Defibrillators; Draft
June 24, 1996
ODE/DCRD
Do
965
Carotid Stent—Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications
October 26, 1996
ODE/DCRD
Do
974
Emergency Resuscitator Guidance; Draft
April 14, 1993
ODE/DCRD
Do
985
Review Guidelines for Oxygen Generators and Oxygen Equipment; Draft Document
April 14, 1993
ODE/DCRD
Do
986
Draft 510(k) Checklist for Condom Catheters
February 23, 1995
ODE/DCRD
Do
991
CDRH Interim Regulatory Policy for External Penile Rigidity Devices
September 10, 1997
ODE/DCRD
Do
992
Reviewer Guidance on Face Masks and Shield for CPR; Draft
March 16, 1994
ODE/DCRD
Do
996
General Guidance Document: Non-Invasive Pulse Oximeter
September 7, 1992
ODE/DCRD
Do
997
Guidance for Peak Flow Meters for Over-the-Counter Sale
June 23, 1992
ODE/DCRD
Do
998
510(K) Submission Requirements for Peak Flow Meters; Draft
January 13, 1994
ODE/DCRD
Do
999
Guidance for Industry and FDA; Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions
February 21, 2000
ODE/DCRD
Do
1126
Guidance Document for Premarket Notification Submission for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final
January 24, 2000
ODE/D
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