Regulatory Guidances

Our collection of FDA Guidance Documents is organized by year. Clicking on a link in the table immediately below will take you to the list for the year indicated. The table is arranged from most recent documents (at the top) to oldest documents. The much larger tables that contain descriptions and links to copies of the documents themselves start with the current year and work backwards to make browsing the lists easier. New FDA guidance documents can be found at http://www.fda.gov/cber/whatsnew.htm.

1999 1998 1997 1996 1995 1994 1993 1992 1991 1990

2000-2008
1990-1999
1980-1989
1970-1979
electronic submissions guidances
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GUIDANCE DOCUMENTS 1999-1990

1999
Top of Page

Date Issued
Title
 Pages Doc
(.pdf)
12/23/99

Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts (DRAFT)

 11
12/21/99
Guidance for Industry:  Special Protocol Assessment (DRAFT) FDA199912E
 12
12/14/99
In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 FDA199912B
 24

12/7/99
Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis and Impact on Dosing and Labeling (DRAFT) FDA199912A
 20

12/1/99

Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports (Federal Register Document - Proposed Rule) FDA199912D
 10
11/24/99
In Vivo Drug Metabolism / Drug Interaction Studies - Study Design, Data Analysis and Recommendations for Dosing and Labeling
19
11/23/99
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
 18
11/22/99
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) FDA199911B

CBER Computer Assisted License Application (CALA) Questionnaire (PDF)

 65
11/3/99
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 (DRAFT) FDA199911A
 16
10/99
Classifying Resubmissions in Response to Action Letters; CDER DA199910D
 4
10/20/99
Biological Products Regulated Under Section 351 of the Public Health Services Act; Implementation of Biologics License; Elimination of Establishment License and Product License (Federal Register Document - Proposed Rule) FDA199910C
 14
10/8/99
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act FDA199910A
 25
10/5/99
New Drug and Biological Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted (Federal Register Document - Proposed Rule) FDA199910Ffr
 11
10/5/99
Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best Interests of Recipients; Revocation of 1990 Interim Final Rule; (Federal Register Document - New Interim Final Rule) FDA199910Efr
 11
9/30/99
Suitability Determination for Donors of Human Cellular and Tissue-Based Products; (Federal Register Document - Proposed Rule) FDA199909Dfr
 28
9/24/99
International Conference on Harmonisation Draft Guidance; Choice of Control Group in Clinical Trials (Federal Register Document - Notice) FDA199909C
 14
9/13/99
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications FDA199909B
 15
9/1/99
Guidance for Industry: Revised Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors (DRAFT) FDA199909A
 9
8/27/99
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products FDA199908F
 4
8/18/99
Q6B International Conference on Harmonisation (ICH); Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Federal Register Document - Notice) FDA199908Efr
 8
8/17/99
Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (DRAFT) FDA199908D
 8
8/17/99
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 FDA199908C
 17
8/6/99
Guidance for Industry Consumer-Directed Broadcast Advertisements FDA199908B
 6
8/3/99
Cooperative Manufacturing Arrangements for Licensed Biologics (DRAFT) FDA199908A
 13
7/24/99
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (DRAFT) FDA199907C
 7
7/15/99
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) (DRAFT) FDA199907B

Previous Version:

Draft 2/12/98 FDA199802B
12
7/7/99
Container Closure Systems for Packaging Human Drugs and Biologics FFCC99
 56
6/28/99
Supplements and Other Changes to an Approved Application FDA199906Efr
 18
6/25/99
S4A ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability
 2  
6/25/99
Monoclonal Antibodies Used as Reagents in Drug Manufacturing FDA199906D
 17
6/17/99
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) FDA199906C
 28
6/4/99
Establishing Pregnancy Registries (DRAFT) FDA199906B
 26
6/4/99
Evaluation of Human Pregnancy Outcome Data FDA199906A
 34
5/20/99
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use FDA199905D
 5
5/20/99
Guidance for Industry: For Platelet Testing and Evaluation of Platelet Substitute Products (DRAFT) FDA199905C
 9
5/14/99
Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); (Federal Register Document - Direct Final Rule) FDA199905Efr
 6
5/10/99
Guidance for Industry: Computerized Systems Used in Clinical Trials FDA199905B
 10
5/10/99
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” FDA199905A

Previous Version:

Draft 7/9/98
FDA199807B
33
4/23/99
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 FDA199904C

Previous Version:

Draft 8/27/98
FDA199808C
27
4/20/99
Investigational New Drug Applications; Clinical Holds; Confirmation of Effective Date (Federal Register Document - Direct Final Rule; Confirmation of Effective Date) FDA199904Bfr

Corresponding Documents:

Direct Final 12/14/98 FDA199812Afr
Proposed 12/14/98 FDA199812Bfr
1
3/19/99
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products (DRAFT) FDA199903D
 13
3/19/99
Guidance for Industry Formal Dispute Resolution: Appeals Above the Division Level (DRAFT) FDA199903C
 12
3/11/99 7
3/8/99
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product

Previous Version:
Draft 11/10/98
FDA199811A
22
2/17/99
Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA) FDA199902C

Previous Versions:

Draft 3/18/98
FDA199803C
Draft 1/6/97
FDA199701B
50
2/17/99
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products or Animal Plasma or Serum-Derived Products FDA199902B

Previous Version:

Draft 12/25/97 FDA199712A
19
2/99
INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products; Chemistry, Manufacturing, and Controls Content and Format (DRAFT) FDA199904A
 18
2/10/99
Guidance for Industry: Population Pharmacokinetics FDA199902D
 35
2/3/99
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products FDA199902A

Previous Version:

Draft 3/13/97 FDA199703A
10
1/29/99
Guidance for Industry: Providing Regulatory Submissions in Electronic Format - NDAs FDA199901E

Previous Version:

Draft 5/13/98
FDA199804D
74
1/28/99
Providing Regulatory Submissions in Electronic Format - General Considerations FDA199901D

Previous Versions:

Draft 5/13/98
Draft 5/13/98
Draft 5/13/98
Draft 5/13/98
Draft 11/4/96
Draft 11/4/96
17
1/26/99
Guidance on Amended Procedures for Advisory Panel Meetings FDA199901C
 5
1/21/99
Guidance for Industry: Content and Format for Geriatric Labeling FDA199901B
 13
1/5/99
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product FDA199901A

Previous Version:

Draft 6/18/98 FDA199806E
34

1998
Top of Page

Date Issued
Title
 Pages Doc
(.pdf)
12/14/98
Bioanalytical Methods Validation for Human Studies (DRAFT) (CDER) FDA199812C)
 16
12/14/98
Investigational New Drug Applications; Clinical Holds (Federal Register Document - Direct Final Rule) FDA199812Afr)
3
12/14/98
Investigational New Drug Applications; Clinical Holds (Federal Register Document - Companion Document to Direct Final Rule) FDA199812Bfr)
3
11/30/98
Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (DRAFT) FDA199811D
 11
11/24/98
FDA Plan for Statutory Compliance (Federal Register Document - Notice) FDA199811Gfr
42
11/24/98
Food and Drug Administration Modernization Act of 1997: FDA Plan for Statutory Compliance FDA199811G
75
11/24/98
Import for Export; Reporting and Record keeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export (Federal Register Document - Proposed Rule) FDA199811Ffr
8
11/20/98
Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices (Federal Register Document - Final Rule) FDA199811Efr
34
11/19/98
Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (DRAFT) FDA199811C
18
11/18/98
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review FDA199811B
Appendix 1: Section 112 of the FDAMA of 1997 Within guidance
Appendix 2: Procedures for Drugs Intended to Treat Life-Threatening and Severely Debilitatiing Ilnesses (10/21/88)
Appendix 3: Priority Review Policies (SOPP 8405)
Appendix 4: Accelerated Approval of New Drugs and Biological Products for Serious or Life-Threatening Illnesses (MAPP 6020.3)
56
11/10/98
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product (DRAFT) FDA199811A
20
10/30/98
Guidance for Industry: Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 FDA199810B
9
10/14/98
Guidance for Industry: Developing Medical Imaging Drugs and Biologics (DRAFT) FDA199810A
46
10/2/98
 Draft Guidance for Industry: Submitting Debarment Certification Statements 15
9/24/98
Q5A ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
 11
9/21/98
ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
6
9/16/98
E9 ICH Guidance on Statistical Principles for Clinical Trials
 16
9/8/98
Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) FDA199809A
21
9/4/98
Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production; CDER (DRAFT) FDA199809B
 13
8/27/98
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 (DRAFT) FDA199808C
28
8/11/98
Biological Products Regulated Under Section 351 of the Public Health Services Act; Implementation of Biologics License; Elimination of Establishment License and Product License (Federal Register Document - Proposed Rule) FDA199808Bfr
2
8/5/98
Revisions to the General Safety Test Requirements for Biological Products (Federal Register Document - Direct Final Rule) FDA199808Afr

Previous Versions:

Final 4/20/98 FDA199804Afr

Proposed 4/20/98 FDA199804Bfr

1
7/31/98
Biological Products Regulated Under Section 351 of the Public Health Services Act; Implementation of Biologics License; Elimination of Establishment License and Product License (Federal Register Document - Proposed Rule) FDA199807Efr
14
7/27/98
Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications FDA199807D

Previous Version:

Draft 11/97 FDA199711A

41
7/21/98
Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements FDA199807C

Previous Version:

Draft 2/98 FDA199802A

6
7/9/98
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 FDA Form 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use” (DRAFT) FDA199807B
28
7/9/98
Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type 1 (DRAFT) FDA199807A
17
7/1/98

PDUFA II: Five - Year Plan; 1998 - 1999 - 2000 - 2001 - 2002 FDA199807F

Other PDUFA Documents:

SOPP 5/20/98 SOPP 8405.1

Goals 10/97 FDA199710E

76
6/29/98
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act FDA199806F
19
6/18/98
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product FDA199806E
34
6/12/98
Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 (Federal Register Document - Notice) FDA199806Dfr
16
6/11/98
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing FDA199806C
3
6/10/98
E5 ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data
 7
6/8/98
Dissemination of Information on Unapproved/ New Uses for Marketed Drugs, Biologics, and Devices (Federal Register Document - Proposed Rule) FDA199806Bfr
19
6/8/98
Guidance for Industry: Stability Testing of Drug Substances and Drug Products (DRAFT) F*Withdrawn 6/1/06 A199806A

Corresponding ICH Document:

ICH 10/27/93 ICHQ1A

114
5/15/98
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements FDA199805G
4
5/15/98
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products FDA199805F

Previous Version:

Draft 3/13/97 FDA199703B

22
5/15/98
Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling FDA199805E
17
5/14/98
Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; (Federal Register Document - Proposed Rule) FDA199805Kfr
 12
5/14/98
Guidance for Industry: Classifying Resubmissions in Response to Action Letters FDA199805D
4
5/14/98
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds FDA199805C
4
5/13/98
Guidance for Industry: Electronic Submissions of a Biologics License Application (BLA) or Product License Application (PLA)/ Establishment License Application (ELA) to the Center for Biologics Evaluation and Research FDA199805A
47
5/13/98
Guidance for Industry: Pilot Program for Electronic Investigational New Drug (eIND) Applications for Biological Products FDA199805B
30
5/13/98
Guidance for Industry: Instructions For Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research (DRAFT) FDA199805I
8
5/13/98

Guidance for Industry: Electronic Submissions of Case Report Forms (CRFs), Case Report Tabulations (CRTs) and Data to the Center for Biologics Evaluation and Research (DRAFT) FDA199805

Previous Version:

Draft 11/4/96 FDA199611B