Guidance Documents

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.

2019 2018 2017 2016 2015 2014 2013 2012 2011 2010
2009 2008 2007 2006 2005 2004 2003 2002 2001 2000
1999 1998 1997 1996 1995 1994 1993 1992 1991 1990
1989 1988 1987 1986 1985 1984 1983 1982 1981 1980
1979 1978 1977 1976 1975 1974 1973 1972 1971 1970

2010-2019

2000-2009

1990-1999
1980-1989
1970-1979
electronic submissions guidances
All Available Guidance Documents
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The "All Available Guidance Documents" page contains all available guidance documents archived by BCG. Use this page to search for a particular type of guidance document using a key word.


GUIDANCE DOCUMENTS (2010 - 2019)

Date Issued
Title
Pages
Doc
(.pdf)
03/2010
Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indication 50

GUIDANCE DOCUMENTS (2009 - 2000)

2009

Date Issued
Title
Pages
Doc
(.pdf)
12/2009
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components 67
11/13/09
Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus 10
11/06/09
Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion 12
10/2009
Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications 50
10/2009
Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications 11
10/2009
Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications 50
10/2009
Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications 11
10/2009
Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information 9
10/2009
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects 18
10/2009
SPL Standard for Content of Labeling Technical Qs & As 11
09/16/09
Guidance for Industry Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation
34
09/2009
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications 39
09/2009
Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines 
15
09/2009
Guidance for Industry Considerations for Allogeneic Pancreatic Islet Cell Products
14
08/06/09
Guidance for Industry Pharmaceutical Components at Risk for Melamine Contamination
8
08/31/09
Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection  6
07/29/09
Drug-Induced Liver Injury: Premarketing Clinical Evaluation
28
07/28/09
Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products 
7
07/15/09
Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act
16
07/13/09
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
11
06/26/09
Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
12
06/08/09
Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events
7
06/02/09
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application
39
06/02/09
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products
27
05/28/09
Providing Regulatory Submissions in Electronic Format –Drug Establishment Registration and Drug Listing
16
05/2009
Formal Meetings Between the FDA and Sponsors or Applicants 
14
05/2009
Presenting Risk Information in Prescription Drug and Medical Device Promotion 27
04/2009
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products 27
04/20/09
Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
10
03/26/09
Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products
16
03/13/09
Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications
12
03/03/09
Draft Guidance for Industry - Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products— Content and Format
14
01/22/09
Draft Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages -
4
01/16/09
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule
19
01/16/09
Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
61
01/05/09
Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices
37
01/2009
Guidance for Clinical Investigators, Sponsors, and IRBs 9

2008

Date Issued
Title
Pages
Doc
(.pdf)
12/16/08
Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability 15
12/11/08
Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process 29
12/11/08
FEDERAL REGISTER: Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval--the Premarket Approval Supplement Decisionmaking Process
2
11/2008
Process Validation: General Principles and Practices 20
11/28/08

Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

  • FEDERAL REGISTER: Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (12/4/08)

18

2

11/21/08
Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names
20
09/17/08
International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies
13
9/9/08
Concept Paper: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule
17
09/8/08
Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases
11
09/4/08
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
28
08/27/08
Draft Guidance for Industry on Integrated Summary of Effectiveness
16
08/07/08
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
23
8/07/08
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
25
08/07/08
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers
14
08/07/08
Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings
6
08/07/08
Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members
20
08/07/08
Draft Guidance for the Public and FDA Staff: Convening Advisory Committee Meetings
6
08/07/08
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
4
08/07/08
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
4
08/07/08
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
4
08/07/08
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter
6
08/05/08
International Conference on Harmonisation (ICH); Draft Guideline: E2F Development Safety Update Report
34
08/05/08
Draft Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
9
07/30/08
Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products
7
07/29/08
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions -Statement of Investigator (Form FDA 1572) 13
07/17/08
Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
17
07/15/08

CGMP for Phase 1 Investigational Drugs

Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials (21 CFR Part 210)

20

11

06/17/08
Guidance for Industry: Indexing Structured Product Labeling (Revision 1)
9
06/11/08
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports
11
06/11/08
Providing Regulatory Submissions in Electronic Format - Postmarketing Individual Case Safety Reports
11
06/05/08
International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances
17 6/5/08
06/2008
Indexing Structured Product Labeling 9 6/5/08
05/30/08
Guidance for Industry: Indexing Structured Product Labeling
9 4/25/08
05/21/08
Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
14 4/25/08
05/20/08
Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
10 4/25/08
04/28/08
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
17 4/25/08
04/25/08
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
14
4/25/08
04/21/08
Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007
4
4/21/08
04/16/08
Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests
10
4/16/08
04/09/08
Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
39
04/09/08
Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
44
04/07/08
International Conference on Harmonisation (ICH); Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
10
03/25/08
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
38
03/07/08
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
14
03/07/08
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
15
02/28/08
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements 14
02/22/08
Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
9
02/21/08

ICHQ4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (8/6/07)

Annex 1: Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC) (8/7/06)

14


6


02/11/08
Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products
14
01/10/08

International Conference on Harmonisation (ICH); Draft Guidance: Q8(R1) Pharmaceutical Development Revision 1

  • ICH Q8 Pharmaceutical Development (5/19/06)
16
01/11/08
FDA Licenses 14 New Blood-Typing Tests
New tests help assure safe transfusions
1

2007

Date Issued
Title
Pages
Doc
(.pdf)
12/31/07
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
14
12/17/07
Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
34
12/14/07

Draft ICH Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter

Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter




4


7

 



11/29/07
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
8
11/27/07
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols
8
11/21/07
Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAG) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
6
11/1/07
Draft Guidance for the Public, FDA Advisory Committee and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information Waivers
12
10/29/07
Draft Guidance for Industry and FDA Staff: Invitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
49
10/29/07
Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
13
10/26/07
Guidance for Industry: Blood Establishment Computer System Validation in User's Facility
11
10/24/07
Guidance for Industry: Drug Induced Liver Damage - Premarketing Clinical Evaluation
26
10/24/07
Guidance for Industry, FDA and Foreign Governments: FY 2008 Medical Device User Fee Small Business Qualification and Certification
34
10/18/07
Federal Register/Vol. 72, No. 201 / Rules and Regulations
4
10/18/07
Federal Register/Vol. 72, No. 201 / Proposed Rules
4
09/27/07
Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
10
09/14/07
Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
13
09/6/07
Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms
17
08/28/07
Draft Guidance for Industry: Pharmacogenomic Data Submissions - Companion Guidance
28
08/24/07
Guidance for Industry: Pharmacogenomic Data Submissions - Companion Guidance
28
08/24/07
Guidance for Industry: Regulation of Human Cells, Tissues and Cellular and Tissue Based Products (HCTP/s) Small Entity Compliance Guide
15

 

08/24/07
Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV
20
08/8/07
Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
29
08/7/07
Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAG) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
6
07/31/07
Guidance: Emergency Use Authorization of Medical Products
16
07/24/07
Guidance for Industry: Exports under the FDA Export Reform and Enhancement Act of 1996
61
07/24/07
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays
15
07/23/07
Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
7
07/23/07
Federal Register Vol.72, No.140/ Notices
3
07/20/07
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
17
07/12/07
International Conference on Harmonisation (ICH); Draft Guidance: Q10 Pharmaceutical Quality System
19
07/06/07
Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
19
07/02/07
Draft Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
10
06/22/07
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
17
06/20/07
Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
9
06/20/07
Draft Guidance for Industry: "Computer Crossmatch" (Electronic Based Testing for the Compatability between the Donor's Cell Type and the Recipient's Serum or Plasma Type)
14
06/04/07
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Receipt Date
9
05/31/07
Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
20
05/31/07
Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
17
05/15/07
Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
22
05/10/07
Guidance for Industry: Computerized Systems Used in Clinical Investigations
13
05/10/07
Draft Guidance for Industry: Protecting the Rights, Safety and Welfare of Study Subjects - Supervisory Responsibility of Investigators
19
04/17/07
Draft Guidance for Clinical Investigators, Sponsors and IRBs Adverse Event Reporting - Improving Human Subject Protections
11
04/2007
Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products 13
03/26/07
Draft Guidance for Industry and FDA Staff: Modifications to Devices Subject to Pre Market Approval (PMA) - The PMA Supplement Decision Making Process
32
02/27/07
Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members
19
02/27/07
Draft Guidance for Industry: Complimentary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
17
 
Comment to the Docket on the "Draft Guidance for Industry: Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration
1
02/27/07
Guidance for Industry: Eligibility Determination for Donors of Human Cells,Tissues, and Cellular and Tissue Based Products (HCT/Ps)
71
01/31/07
Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
19
01/23/07
Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests
10
01/16/07
Draft Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
49
01/8/07
ICH Draft Guidance E15 Terminology in Pharmacogenomics
8

2006

Date Issued
Title
Pages
Doc
(.pdf)
11/28/06
Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events
25
11/28/06
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
15
10/27/06
Guidance for Industry: Implementation of Acceptable Full Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
10
10/30/06
Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
17
10/18/06
Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
20
10/18/06
Guidance for Industry: Biological Product Deviation Report for Blood and Plasma Establishments
32
10/05/06
Guidance for Industry: Bar Code Label Requirements - Questions and Answers
13
09/29/06
Federal Register /Vol.71, No. 189/ September 29, 2006/ Notices
2
09/29/06
Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
32
09/28/06
ICH E5 Ethnic Factors: Questions and Answers
10
09/28/06
Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
52
09/22/06
Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
5
09/22/06
United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128
90
09/11/06
Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling
55
09/08/06
Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) - Manufacturing Arrangements
5
09/07/06
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors - Exception from Informed Consent Requirements for Emergency Research
30
09/02/06
Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
7
09/01/06
Federal Register - Annual Guidance Agenda
12
08/29/06
Federal Register: Requirements for Foreign an Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Proposed Rule
83
08/08/06
Guidance for Industry: Amendment (Donor Deferal for Transfuion in France Since 1980) to "Guidance for Industry: Revised Preventative Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jacob Disease (CJD) and Variant Creutzfeldt-Jacob Disease (vCJD) by Blood and Blood Products"
6
08/08/06
Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G(IgG)
6
08/07/06
ICHQ4B Draft Guidance: Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)
7
08/07/06

ICHQ4B Draft Guidance: Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)

Annex 1: Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)

4
07/2006
ICH Q3B(R2) Impurities in New Drug Products
18
06/12/06
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation (CBER) in Electronic Format - Lot Release Protocols
9
06/01/06
Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment
22
06/01/06
ICH Q9 Quality Risk Management
25

05/19/06
ICH Q8 Pharmaceutical Development
12
05/04/06
Guidance for Industry: Development of Preventative HIV Vaccines for Use in Pediatric Populations
9
04/27/06
Guidance for Industry: Bar Code Label Requirements - Questions and Answers
11
04/25/06
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimans that are not Individually Identifiable
10
04/25/06
Draft Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
9
04/19/06
Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
20
ICH 04/12/06
Guidance for Industry: S8 Immunotoxicity Studies for Human Pharmaceuticals
16
03/28/06
Federal Register: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
46
03/27/06
Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
38
03/15/06
Guidance for Industry: Using a Centralizled IRB Review Process in Multicenter Clinical Trials

10

03/02/06
Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Infuenza Vaccines
17
03/02/06
Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
14

02/15/06

Guidance for Industry: Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization of 1997
25
02/13/06
Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
14

02/02/06

Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
36
01/2006

Guidance for Industry, Investigators, and Reviewers

Exploratory IND Studies

16
01/18/06
Guidance for Industry: Labeling for Human Prescription Drug and Biological Products - Implementing the New Content and Format Requirements
31
01/18/06
Guidance for Industry: Warning and Precautions Contraindications and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format
14
01/18/06
Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
25
01/18/06
Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Produt - Content and Format
16
01/12/06
Draft Guidance for Industry: INDs - Approaches to Complying with cGMP During Phase 1
20
01/11/06
Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical cGMP
16
01/11/06
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development and Application Review
25
 

Appendix 2

9
Appendix 3 CDER MAPP 6020.3
4
Appendix 4
19

2005

Date Issued
Title
Pages Doc
(.pdf)
12/30/05
Draft Guidance for Industry: Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees
38
12/30/05
Federal Register Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
3
11/23/05
FR Final Rule
21
11/30/05
Draft Guidance for Industry: Safety, Efficacy and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
13
11/30/05
Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps)
9
10/19/05
Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
7
10/19/05
ICH Guidance for Industry: E14 Clinical evaluation of QT/QTc Intreval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
20
10/19/05
ICH Guidance for Industry: S7B Nonclinical evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
13
10/18/05
Guidance for Inudstry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
20
10/18/05
ICH Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD
13
10/07/05
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
11
09/30/05
Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods 9/30/05
37
09/30/05
ICH Guidance for Industry: E2B(R) Clinical Safety Data Management: Data Elements for Transmissons of Individual Case Safety Reports
26
09/29/05
Draft Guidance for Industry: Using Electronic Means to Distribute Certain Product Information
8

 

09/19/05
Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials
21
09/15/05
Guidance for Industry, FDA Staff, and FDA - Accredited Third Parties - Requests for Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002
23
09/07/05
Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act
21
09/02/05
ICH Consensus Guideline Released for Consultation on 10 May 2005 at Step 2 - Data Elements and Standards for Drug Dictionaries M5
31
08/23/05
Draft Guidance for Industry: Gene Therapy Clinical Trials-Observing Participants for Delayed Adverse Events
26
08/2005
Guidance for Industry and FDA Staff: How to Write a Request for Designaton (RFD)
20
08/05/05
ICH: Draft Consensus Guideline: Q9 Quality Risk Management
23
07/19/05
Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
44
07/05/05
Draft Guidance: Emergency Use Authorizaton of Medical Products
50
06/30/05
Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection" *Withdrawn
1
06/29/05
International Conference for Harmonization (ICH) Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
17
06/28/05
Federal Register: Draft Guidance for Food and Drug Administraton Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance
1
06/23/05
Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
15
06/07/05
Draft Guidance for Industry: Bar Code Label Requirements - Questions and Answers
10
05/18/05
Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
12
05/12/05
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
23
05/06/05
Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection
4
04/29/05
Draft Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
10
04/27/05
Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies
31
04/20/05
Guidance for Industry and FDA Staff: Application User Fees for Combination Products
19
04/20/05
Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling
8
04/14/05
Draft Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
14
04/11/05
Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product
9
04/2005
Guidance for Industry, Investigators, and Reviews - Exploratory IND Studies
16
04/01/05
Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
26
03/31/05
International Conference of Harmonisation (ICH); Guidance for Industry: E2E Pharmacovigilance Planning
21
03/31/05
Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products
35
03/25/05
Guidance for Industry: Premarketing Risk Assessment
28
03/25/05
Guidance for Industry: Development and Use of Risk Minimization Action Plans
27
03/25/05
Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
23
03/25/05
Draft Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials
10
03/22/05
Guidance for Industry: Pharmacogenomic Data Submissions
28
03/22/05
Attachment to Guidance on Pharmacogenomic Data Submissions
12
03/11/05
International Conference on Harmonisation (ICH) M2: eCTD Specification Companion Document: Current Q&As and Change Requests
30
03/11/05
International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests
5
03/09/05
International Conference on Harmonisation (ICH); Guidance for Industry: E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 2)
20
02/23/05
Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms
19
02/17/05
Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
14
02/08/05
International Conference on Harmonisation (ICH); Draft Guidance on Q8 Pharmaceutical Development
11
02/07/05
International Conference on Harmonisation (ICH); Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
13
02/07/05

Draft Guidance for Industry: Clinical Lactation Studies - Study Design, Data Analysis and Recommendations for Labeling

22
01/03/05
Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees
10

 

2004
Top of Page

Date Issued

Title

Pages

Doc
(.pdf)

12/22/04
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- General: Questions and Answers (Revision 3)
11
12/22/04
International Conference on Harmonisation (ICH); Guidance for Industry: M4: CTD -- Efficacy: Questions and Answers (Revision 3)
12
11/30/04
Draft Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
12
11/19/04
Guidance for Industry: Continuous Marketing Applications: Pilot 2-Scientific Feedback and Interactons During Development of Fast Track Products Under the Prescription Drug User fee Act of 1992; Notice of extension of application deadline
2
11/17/04
Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA
35
11/12/04
Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
9
11/08/04
Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigantional New Drug Applications (INDs)
44
10/28/04
Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
19
10/21/04
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
13
10/1/04
Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria
31
10/01/04
Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
8
09/29/04
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Currrent Good Manufacturing Practice
63
09/29/04
Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
33
09/29/04
Draft Guidance for Industry and FDA: Current Good Manufacturing Practice for Combination Products
11
09/29/04
Draft Guidance for Industry: Computerized Systems Used in Clinical Trials
18
09/23/04
Draft Guidance for Industry and FDA Staff: Application User Fees for Comination Products

15

09/23/04
Federal Register Annual Guidance Agenda
31
09/10/04
International Conference on Harmonisation (ICH); Draft Guidance: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
16
09/10/04
International Conference on Harmonisation (ICH); S7B Guideline: Step 2 Revision: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
10
09/2/04
Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct
11
08/30/04
Guidance on Research Involving Coded Private Information or Biological Specimens
7
08/20/04
Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification
16
08/18/04
Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols
7
07/21/04

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review

  • Appendix 2 (23 pages)
  • Appendix 3 CDER MAPP 6020.3 (4 pages)
  • Appendix 4 (4 pages)
23
07/21/04
Guidance for Industry: Available Therapy (FDA200407A)
9
07/12/04
Guidance for Industry: FDA Export Certificates
9
07/2/04
International Conference on Harmonisation (ICH); Guidance for Industry: Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV
8
06/17/04
Guidance for Industry: Developing Medical Imaging Drug and Biological Products Part 3
21
06/17/04
Guidance for Industry: Developing Medical Imaging Drug and Biological Products Part 2
21
06/17/04
Guidance for Industry: Developing Medical Imaging Drug and Biological Products Part 1
21
06/08/04
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Quality: Questions and Answers/Location Issues
25
06/07/04
International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data
21
06/03/04
Draft Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: FDA Staff, and FDA-Accredited Third Parties: Requests for Inspections by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002
13
06/03/04
International Conference on Harmonisation (ICH); Guidance for Industry: E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data - Questions and Answers
9
05/28/04
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s)
11
05/20/04
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
18
05/20/04
Draft Guidance for Industry: Eligibility Determination Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
52
05/05/04
International Conference on Harmonisation (ICH); Guidance for Industry: E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 1)
20
05/04/04
Draft Guidance for Industry: Premarketing Risk Assessment
26
05/04/04
Draft Guidance for Industry: Development and Use of Risk Minimization Action Plans
24
05/04/04
Draft Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
22
05/04/04
Draft Guidance for Industry: Combination Products, Timeliness of Premarket Reviews, Dispute Resolution
8
03/29/04
International Conference on Harmonisation (ICH); Draft Guidance: E2E Pharmacovigilance Planning (PvP)
16
03/29/04
International Conference on Harmonisation (ICH); Draft Guidance: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
11
03/08/04
Draft Guidance for Industry: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination
40
02/04/04
Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices
8
02/04/04

Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements

    Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) (1 Page)
    Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement (1 Page)
11
02/04/04
International Conference on Harmonisation (ICH); Guidance for Industry: Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
12
02/04/04
Draft Guidance for Industry: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms
10
02/02/04
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling
7
01/26/04
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1)
13
01/23/04
FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Opportunity for Public Comment
4
01/16/04
Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revision 1)
12
01/08/04
FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction
1
01/06/04
Draft Guidance for Industry: Drug Substance - Chemistry, Manufacturing, and Controls Information
66

 

2003
Top of Page

Date Issued
Title
Pages Doc
(.pdf)
12/30/2003
FEDERAL REGISTER Revision of the Requirements for Spore-Forming Microorganisms; Direct Final Rule
4
12/30/2003
FEDERAL REGISTER Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule; Proposed Rule
4
12/18/2003
FEDERAL REGISTER Neurological Devices; Classification of Human Dura Mater; Final Rule
2
12/17/2003
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Human Dura Mater
18
12/11/2003
FEDERAL REGISTER Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Final Rule
12
12/09/2003
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
47
11/21/2003
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
20
11/21/2003
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications
15
11/21/2003
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
18
11/20/03
International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products
25
11/12/03
International Conference on Harmonisation (ICH); Guidance for Industry: Q3C - Tables and List
10
11/13/03
International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R) Impurities in New Drug Products
18
11/03/03
Draft Guidance for Industry: Pharmacogenomic Data Submissions
29
10/31/03
Guidance for Industry: Product Recalls, Including Removals and Corrections
13
10/31/03
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review
17
10/30/03
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus
13
10/30/03
FEDERAL REGISTER Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay - Final Rule
3
10/28/03
Draft Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
12
10/22/03
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations
24
10/8/03
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment
26
10/7/03
FEDERAL REGISTER Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma; Correction - Proposed Rule; correction
1
10/6/03
Guidance for Industry: Continuous Marketing Applications: Pilot 1 - Reviewable Units for Fast Track Products Under PDUFA
14
10/6/03
Guidance for Industry: Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
10
9/22/03
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion
7
9/16/03

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

11
9/12/03

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer

11
9/12/03
ICH Draft Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
12
9/3/03

Draft Guidance for Industry: Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information

23
9/3/03

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application

12
9/3/03
Draft Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
15
9/3/03
Draft Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
63
8/28/03
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related Submissions
21
8/27/03

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug Applications and Abbreviated New Drug Applications

5
8/15/03
Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
38
8/1/03
Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification
15
7/28/03
Draft Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products
42
7/24/03
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices
23
7/3/03
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires
11
7/3/03
Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices.
23
06/25/03
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis.
12
06/23/03
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports
16
06/23/03
FEDERAL REGISTER Assignment of Agency Component for Review of Premarket Applications - Final Rule
3
06/11/03
FEDERAL REGISTER New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval; Technical Amendment - Final Rule; Technical Amendment
2
05/30/03
Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
19
05/19/03
Draft Guidance for Industry: Developing Medical Imaging Drug and Biological Products - 5/19/2003
Part 1: Conducting Safety Assessments (19 pages)
Part 2: Clinical Indications (20 pages)
Part 3: Design, Analysis, and Interpretation of Clinical Studies (31 pages)
   
05/12/03
Draft Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols
6
5/03
Guidance for Industry: INDs for Phase 2 and Phase 3 Studies - Chemistry, Manufacturing and Controls Information
27
05/5/03
Guidance for Industry: Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications
28
5/1/03
Guidance for Industry: Revised Recommendatons for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
13
04/4/03
FEDERAL REGISTER - Annual Guidance Agenda
19
04/03/03
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
63
04/01/03
International Conference on Harmonisation (ICH); Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification
131
03/14/03
FEDERAL REGISTER Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule
93
03/13/03
FEDERAL REGISTER Bar Code Label Requirement For Human Drug Products and Blood; Proposed Rule
36
03/12/03
Guidance for Industry and FDA: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
15
03/04/03
FEDERAL REGISTER Revision to the General Safety Requirements for Biological Products; Final Rule
4
02/20/03
Draft Guidance for Industry; Part 11, Electronic Records; Electronic Signatures - Scope and Application
12
02/20/03
Draft Guidance for Industry; Comparability Protocols - Chemistry, Manufacturing, and Controls Information
22
02/13/03
Guidance for Industry (DRAFT) - Comparability Protocols - Chemistry, Manufacturing, and Controls Information
20
2/11/03
International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances
17  
02/04/03
Corrected - Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients
11
02/04/03
FEDERAL REGISTER: Withdrawal of Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
1
2/3/03
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Safety: Questions and Answers
7
1/15/03
International Conference on Harmonisation; Guidance for Industry; Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
11

 

2002
Top of Page

Date Issued
Title
Pages Doc
(.pdf)
12/30/02
Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients
11
12/27/02
International Conference on Harmonisation; Draft Consensus Guideline - Addendum to ICH E2C - Clinical Safety Data Management - Periodic Safety Update Reports for Marketed Drugs
10
12/27/02
International Conference on Harmonisation; Draft Guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues
32
11/12/02
Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
15
10/25/02
Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
11
10/15/02
Draft Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components.
47
10/3/02
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
25
9/27/02
Preliminary Concept Paper (not for implementation): Sterile Drug Products produced by Aseptic Processing draft.
50
9/6/02
Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals
30
9/5/02
Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records
27
8/27/02
Draft Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct
9
6/19/02
FEDERAL REGISTER Investigational New Drugs: Export Requirements for Unapproved New Drug Products; Proposed Rule
7
6/14/02
Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
23
6/13/02
International Conference on Harmonisation (ICH); Draft Consensus Guideline; Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals
24
6/13/02
International Conference on Harmonisation (ICH); Draft Consensus Guideline; Evaluation of Stability Data
16
6/13/02
International Conference on Harmonisation (ICH); Draft Consensus Guideline; Stability Data Package for Registration in Climatic Zones III and IV
5
6/13/02
International Conference on Harmonisation (ICH); Electronic Common Technical Document Specification.
160
6/6/02
FEDERAL REGISTER Postmarket Surveillance; Final Rule
15
5/31/02
FEDERAL REGISTER New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule
11
5/14/02
FEDERAL REGISTER Exports; Notification and Recordkeeping Requirements; Stay; Final Rule; Stay
1
5/02
Guidance for Industry: Carcinogenicity Study Protocol Submissions
9
5/13/02
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers.
4
4/24/02
FEDERAL REGISTER Obtaining Timely Pediatric Studies of and Adequate Pediatric Labeling for Human Drugs and Biologics; Advanced Notice of Proposed Rulemaking
3
4/10/02
A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components and Source Plasma Donations (DRAFT) FDA2002
5
4/9/02
IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products (DRAFT) FDA200204B
11
4/4/02
Guidance for Industry: E2BM Data Elements for Transmission of Individual Case Safety Reports FDA200204A
34
3/2002
Guidance for Industry: Information Program on Clinical Trials for Serious or Life threatening Diseases and Conditions.
12
3/26/02
Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs) FDA200203D
24
3/18/02
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions FDA200203C
12
3/13/02
Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV (DRAFT) FDA200203B
7
3/8/02
Validation of Procedures for Processing of Human Tissues Intended for Transplantation FDA200203A
4
2/6/02
Available Therapy (DRAFT) FDA200202B
9
2/1/02

Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts (DRAFT) FDA200202A

Previous Versions:

Draft 12/23/99 FDA199912C
12
2/1/02

FEDERAL REGISTER Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs; Final Rule

4
1/11/02
General Principles of Software Validation; Final Guidance for Industry and FDA Staff FDA200201B
47
1/9/02

Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products FDA200201A

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

35

2001
Top of Page

Date Issued
Title
Pages Doc
(.pdf)
12/4/01
Use of Nucleic Acid Tests on Pooled Samples from Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV (DRAFT) FDA200112A
5
11/27/01
Foreign Establishment Registration and Listing (Federal Register Document - Final Rule) FDA200111Dfr
24
11/21/01
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act FDA200111C
8
11/19/01
National Institute of Health; Office of Biotechnology Activities; Recombinant DNA Research: Actions Under the NIH Guidelines (Federal Register Document - Notice of actions under the Guidelines for research involving recombinant DNA molecules; NIH Guidelines) NIH200111Efr
8
11/15/01
Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees (DRAFT) FDA200111B
27
11/13/01
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations FDA200111A
64
10/17/01
Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax FDA200110C
9
10/16/01
ICH M4: Organization of the CTD
10
10/16/01
ICH M4E: The CTD - Efficacy
63
10/16/01
ICH M4Q: The CTD - Quality
34
10/16/01
ICH M4S: The CTD - Safety
26
10/16/01
ICH M4S: The CTD - Safety Appendices
97
10/5/01
Content and Format of Geriatric Labeling FDA200110B
13
10/5/01
Cancer Drug and Biological Products - Clinical Data in Marketing Applications FDA200110A
13
9/25/01
International Conference on Harmonisation (ICH) Guidance; Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients FDA200109D
58
9/24/01
21 CFR Part 11; Electronic Records; Electronic Signatures; Glossary of Terms (DRAFT) FDA200109C
9
9/24/01
21 CFR Part 11; Electronic Records; Electronic Signatures; Validation (DRAFT) FDA200109B
24
9/5/01
Submitting Marketing Applications According to the ICH-CTD Format - General Considerations (DRAFT) FDA200109A
20
8/28/01
Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls FDA200108H
24
8/27/01
Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (DRAFT) FDA200108G
26
8/22/01
Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research FDA200108F
7
8/22/01
Variances for Blood Collection from Individuals with Hereditary Hemochromatosis FDA200108E
7
8/10/01
Biological Product Deviation Reporting for Blood and Plasma Establishments (DRAFT) FDA200108D
27
8/10/01
Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components (DRAFT) FDA200108C
19
8/7/01
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture FDA200108B
32
8/6/01
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Final Rule
5
8/3/01
FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments (DRAFT) FDA200108A
12
7/19/01
FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers FDA200107F
8
7/19/01
FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) FDA2001
7
7/19/01
FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components FDA200107D
7
7/12/01
ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals FDA200107G
14
7/11/01
Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors FDA200107C
7

7/11/01

 

CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From An Outside Supplier *Guidance withdrawn 4/11/06. FR Vol.71, No.69 FDA200107B
14
7/9/01
Clinical Studies Section of Labeling for Prescription Drugs and Biologics--Content and Format (DRAFT) FDA200107A
19
6/29/01
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan (DRAFT) FDA20
7
6/11/01
FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents
20
6/11/01
FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents
20
5/25/01
IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information FDA200105C
13
5/14/01
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (DRAFT) FDA200105B
9
5/11/01
ICH Guidance for Industry: E10 Choice of Control Group and Related Issues in Clinical Trials
37
5/3/01
Providing Regulatory Submissions in Electronic Format Post-marketing Expedited Safety Reports FDA200105A
12
5/01
Guidance for Industry Bioanalytical Method Validation
22
4/20/01
Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements (DRAFT) FDA200104B
7
4/4/01
Reports on the Status of Post-marketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (DRAFT) FDA20010
24
3/29/01
Monoclonal Antibodies Used as Reagents in Drug Manufacturing FDA200103D
11
3/28/01
Financial Disclosure by Clinical Investigators FDA200103C
11 (.htm)
3/13/01
Acceptance of Foreign Clinical Studies FDA200103B
4
3/12/01
Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines (DRAFT)  FDA200103A
50
2/22/01
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (DRAFT) FDA200102D
9
2/20/01
Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports (Federal Register Document - Final Rule; delay of effective date) FDA200102Efr
1
2/15/01
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 (DRAFT)
13
2/13/01
Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 F2C
11
2/7/01
Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans (DRAFT) FDA200102A
61
1/31/01
Providing Regulatory Submissions in Electronic Format -- Prescription Drug Advertising and Promotional Labeling (DRAFT) FDA200101D

Corresponding Documents:

Draft 3/11/99 FDA199903B

8
1/30/01
Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods FDA200101C
11
1/23/01
Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion (DRAFT) FDA200101B
24
1/19/01
Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing (Federal Register Document - Final Rule) FDA200101Gfr
23
1/19/01
PHS Guideline on Infectious Disease Issues in Xenotransplantation

Previous Versions:

Draft 10/18/00 FDA200010C
Draft 5/26/00 FDA200005A
Draft 9/23/96 FDA199609Bfr
 
58
1/18/01
Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation (Federal Register Document - Proposed Rule) FDA200101Ffr
19
1/8/01
Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement (Federal Register Document - Proposed Rule)fr
53

2000
Top of Page

Date Issued
Title
Pages Doc
(.pdf)
12/29/00
ICH; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
23
12/22/00
Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels (Federal Register Document - Proposed Rule) FDA200012Cfr
51
12/20/00
Variances for Blood Collection from Individuals with Hereditary Hemochromatosis (DRAFT) FDA200012B
6
4/00
Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (DRAFT) FDA200012A
19
12/15/00
ICH Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population
17
11/22/00
Use of Sterile Connecting Devices in Blood Bank Practices F
10
11/20/00
Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol FDA200011E

Previous Versions:

Draft 2/8/00 FDA200002B
15
11/20/00
Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts FDA200011D

Previous Versions:

Draft 8/25/97 FDA199708C
10
11/9/00
Cancer Drug and Biological Products - Clinical Data in Marketing Applications (DRAFT) FDA200011C
13
11/9/00
Biological Products:  Reporting of Biological Product Deviations in Manufacturing; (Federal Register Document - Final Rule) (Correction of Effective Date, Effective date is May 7, 2001) FDA200011B
1
11/7/00
Biological Products:  Reporting of Biological Product Deviations in Manufacturing; (Federal Register Document - Final Rule) FDA200011A
15
10/30/00
Post-marketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports (Federal Register Document - Final Rule)  FDA200010E
13
10/26/00
Submitting and Reviewing Complete Responses to Clinical Holds FDA200010D
7
10/18/00

Agency Information Collection Activities; Proposed Collection:
Comment Request (Federal Register Notice)

58
10/18/00
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 FDA200010B
15
10/6/00
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients (Federal Register Document - Final Rule; Technical Amendment) FDA200010Ffr
1
10/3/00
Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products FDA200010A
4
9/8/00
Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications (DRAFT) FDA200009A
10
8/30/00
Analytical Procedures and Methods Validation - Chemistry, Manufacturing, and Controls Documentation (DRAFT) FDA200008B
37
8/29/00
Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License (Federal Register Document - Final Rule; Technical Amendment) 8Cfr
1
8/10/00
Botanical Drug Products (DRAFT) FDA200008A
43
7/31/00
Developing Medical Imaging Drugs and Biological Products (DRAFT)
63
7/18/00
CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier (DRAFT) FDA200007A
15
6/28/00
Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment (DRAFT) FDA200006F
22
6/23/00
Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens FDA200006E
4
6/21/00
Pediatric Oncology Studies In Response to a Written Request (DRAFT) FDA200006D
9
6/21/00
Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics (DRAFT) FDA200006C

Guidance for Adverse Reactions Labeling - FDA Talk Paper

15
6/8/00
Recommendations for Donor Questioning Regarding Possible Exposure to Malaria (DRAFT) FDA200006B
7
6/6/00
Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components FDA200006A

United States Industry Consensus Standard for the Uniform labeling of Blood and Blood Components Using ISBT 128 (11/99, 95 pages)

5
5/26/00 58
4/18/00
Suitability Determination for Donors of Human Cellular and Tissue-Based Products; (Federal Register Document - Proposed Rule; reopening of comment period) FDA200004Bfr
2
4/10/00
Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs; (Federal Register Document - Proposed Rule) DA200004Afr
5
3/29/00
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank (DRAFT) FDA200003D)
9

3/15/00

 

Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing *Guidance Withdrawn 4/10/06 FR Vol.71, No.68 FDA200003C
14
3/7/00
Formal Meetings With Sponsors and Applicants for PDUFA Products FDA200003B)
12
3/7/00
Formal Dispute Resolution: Appeals Above the Division Level FDA200003A)
10
2/10/00
ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use
136
 

2/9/00

Special Protocol Assessment (DRAFT) FDA200002C)

12

2/8/00

16

2/4/00

IND Meetings for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information (DRAFT) FDA200002A)

14

1/12/00
New Drug Applications; Drug Master Files (Federal Register Document - Final Rule)  (FDA200001B)
5
1/3/00
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (DRAFT) (FDA200001A)
27

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 FDA199805A
Draft 5/13/98 FDA199805B
Draft 5/13/98 FDA199805H
Draft 5/13/98 FDA199805I
Draft 11/4/96 FDA199611B
Draft 11/4/96 FDA199611A
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)