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

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A01-26650

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** October 24, 2001
- **Citation:** 66 FR 53836

## Text

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 It also provides information on guidance documents that have been added or withdrawn in the past year.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guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn this year are also listed.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 Alloca

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A01-26650. Public record. Not legal advice.