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.
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Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic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 |
|
06/2008 |
Indexing Structured Product Labeling |
9 |
|
05/30/08 |
Guidance for Industry: Indexing Structured Product Labeling |
9 |
|
05/21/08 |
Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products |
14 |
|
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 |
|
04/28/08 |
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application |
17 |
|
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 |
|
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 |
|
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 |
|
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 |
|
|
|
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:
|
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:
|
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:
|
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:
|
15 |
|
| 11/20/00 |
Testing
Limits in Stability Protocols for Standardized Grass Pollen
Extracts FDA200011D
Previous
Versions:
|
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
|