CBER Guidances / Guidelines / Points to Consider

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By Topic -
Allergenics | Blood | Cellular / Gene Therapy | Common Technical Document | Devices | Electronic Submissions | FDAMA | ICH | IND | PDUFA | Tissue | Vaccines | Xenotransplantation
By Year -
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Proposed/Final Rules
Federal Register Notices pertaining to Guidances

Submit comments on Draft Guidances to Federal Dockets Management System (FDMS).

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2009

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - 1/16/2009

  • FEDERAL REGISTER: Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability

International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 79 KB) - 1/9/2009

  • FEDERAL REGISTER: International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Test for Extractable Volume of Parenteral Preparations General Chapter; Availability

International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter (PDF - 1.18 MB) - 1/9/2009

  • FEDERAL REGISTER: International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Test for Particulate Contamination: Subvisible Particles General Chapter; Availability

Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices - 1/5/2009


2008

Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability (PDF-246 KB) - 12/16/2008

Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval--the Premarket Approval Supplement Decisionmaking Process - 12/11/2008

Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics - 11/28/2008

Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF, 256 KB) - 11/21/2008

Draft Guidance for Industry on Process Validation: General Principles and Practices - 11/18/2008

Draft Guidance for Industry on Tropical Disease Priority Review Vouchers - 10/20/2008

Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - 10/9/2008

Concept Paper: PDUFA Pilot Project: Proprietary Name Review (PDF - 295 KB)- 10/7/2008

Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Product (PDF - 125 KB) - 9/30/2008

International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies (PDF - 185 KB) - 9/17/2008

Concept Paper: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF) - 9/9/2008

Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases - 9/8/2008

International Conference on Harmonisation (ICH); Draft Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals - 9/4/2008

Draft Guidance for Industry: Integrated Summary of Effectiveness - 8/27/2008

Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers - 8/7/2008

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 (PDF) - 8/7/2008

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers (PDF) - 8/7/2008

Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings (PDF) - 8/7/2008

Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members (PDF) - 8/7/2008

Draft Guidance for the Public and FDA Staff: Convening Advisory Committee Meetings (PDF) - 8/7/2008

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 (PDF) - 8/7/2008

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 (PDF) - 8/7/2008

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 (PDF) - 8/7/2008

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 (PDF) - 8/7/2008

International Conference on Harmonisation (ICH); Draft Guideline: E2F Development Safety Update Report (PDF) - 8/5/2008

Draft Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 64 KB) - 8/5/2008

Draft Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products - 7/30/2008

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions -Statement of Investigator (Form FDA 1572) - 7/29/2008

Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency - 7/17/2008

Guidance for Industry: CGMP for Phase 1 Investigational Drugs - 7/15/2008

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing - 7/11/2008

Guidance for Industry: Indexing Structured Product Labeling (Revision 1) - 6/17/2008

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Postmarketing Individual Case Safety Reports - 6/11/2008

Technical specifications associated with this guidance will be provided as stand alone documents. They will be updated periodically independent of the guidance. To ensure that you have the most recent versions of the stand alone documents, check the appropriate center's guidance Web page. For CBER, this Web page is http://www.fda.gov/cber/esub/icsr.htm. For CDER, this Web page is http://www.fda.gov/cder/regulatory/ersr/#Postmarketing.

Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications - 6/11/2008

International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances - 6/5/2008

Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products - 5/21/2008

Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) - 5/20/2008

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) - 4/25/2008

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 - 4/21/2008

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 - 4/16/2008

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) - 4/9/2008

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) - 4/9/2008

International Conference on Harmonisation (ICH); Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories - 4/7/2008

International Conference on Harmonisation (ICH); Draft Guidance: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use - 3/25/2008

Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements - 3/7/2008

Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices - 3/7/2008

Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products - 2/22/2008

International Conference on Harmonisation (ICH); Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - 2/21/2008

International Conference on Harmonisation (ICH); Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 1 Residue on Ignition/Sulphated Ash General Chapter - 2/21/2008

Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products - 2/11/2008

International Conference on Harmonisation (ICH); Draft Guidance: Q8(R1) Pharmaceutical Development Revision 1 - 1/10/2008


2007

Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods - 12/17/2007

12/14/2007 - The Guidance for Industry: Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection was issued for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i). The guidance is being withdrawn based upon comments we have received. FDA may revise the guidance and issue a draft guidance for public comment in the future.

International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter - 12/14/2007

International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter - 12/14/2007

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle - 11/29/2007

Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols - 11/27/2007

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 - 11/21/2007

Draft Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions - 10/29/2007

Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications - 10/29/2007

Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility- 10/26/2007

Draft Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation - 10/24/2007

Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification (PDF - 1 MB) - 10/24/2007

Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials - 9/27/2007

Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions - 9/13/2007

Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms - 9/6/2007

Draft Guidance for Industry: Pharmacogenomic Data Submissions - Companion Guidance - 8/28/2007

Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide - 8/24/2007

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 - 8/24/2007

Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - 8/8/2007

Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay - 8/8/2007

Guidance: Emergency Use Authorization of Medical Products - 7/31/2007

Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 - 7/24/2007

Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays - 7/24/2007

Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs) - 7/23/2007

International Conference on Harmonisation (ICH); Draft Guidance: Q10 Pharmaceutical Quality System - 7/12/2007

Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage - 7/6/2007

Draft Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document - 7/2/2007

Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission - 6/22/2007

Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs - 6/20/2007

Draft Guidance for Industry: "Computer Crossmatch" (Electronic Based Testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type) - 6/20/2007

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Receipt Date - 6/5/2007

Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines - 5/31/2007

Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines - 5/31/2007

Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics - 5/15/2007

Guidance for Industry: Computerized Systems Used in Clinical Investigations - 5/10/2007

Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators - 5/10/2007

Draft Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting - Improving Human Subject Protection - 4/17/2007

Draft Guidance for Industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format - 4/9/2007

Draft Guidance for Industry and FDA Staff: Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - 3/26/2007

Draft Guidance for Industry: Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration - 2/27/2007

Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container - 1/31/2007

Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies - 1/16/2007


2006

Guidance for Clinical Investigators, Institutional Review Boards and Sponsors: Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations - 12/22/2006

Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events - 11/28/2006

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 - 11/28/2006

Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components - 10/27/2006

Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) - 10/26/2006

Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - 10/18/2006

Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 10/18/2006

Guidance for Industry: Bar Code Label Requirements - Questions and Answers - 10/5/2006

Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - 9/29/2006

International Conference on Harmonisation (ICH); Guidance for Industry: E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data - Questions and Answers - 9/28/2006

Draft 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 - 9/28/2006

Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels - 9/22/2006

Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update - 9/20/2006

Draft Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling - 9/11/2006

Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) - Manufacturing Arrangements - 9/8/2006

Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research - 9/7/2006

FEDERAL REGISTER - Annual Guidance Agenda - 9/6/2006 - (PDF - 100 KB)

Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies - 8/8/2006

Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "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" - 8/8/2006

International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R2) Impurities in New Drug Products - 7/31/2006

Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment - 6/1/2006

FEDERAL REGISTER: Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Withdrawal and Revision of Seven Guidances
FEDERAL REGISTER: Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Withdrawal and Revision of Seven Guidances (PDF - 54 KB)
- 6/1/2006

International Conference on Harmonisation (ICH); Guidance for Industry: Q9 Quality Risk Management - 6/1/2006

Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations - 5/4/2006

Guidance for Industry and FDA Staff: Real-Time Premarket Approval Application (PMA) Supplements - 4/28/2006

Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - 4/25/2006

FEDERAL REGISTER: Vaccine Adverse Event Reporting; Revised Form VAERS-2; Withdrawal of Proposed Revised Form - 4/21/2006 - (PDF - 44 KB)

International Conference on Harmonisation (ICH); Guidance for Industry: S8 Immunotoxicity Studies for Human Pharmaceuticals - 4/12/2006

FEDERAL REGISTER: Draft Guidance for Industry: Center for Biologics and Evaluation Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier; Withdrawal of Guidance - 4/11/2006 (PDF - 51 KB)

FEDERAL REGISTER: Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing; Withdrawal of Guidance - 4/10/2006 - (PDF - 57 KB)

FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration - 3/28/2006 - (PDF - 244 KB)

Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees - 3/27/2006

Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials - 3/15/2006

Guidance for Industry: Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 - 2/15/2006

Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications - 2/13/2006

Draft Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims - 2/2/2006

Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format - 1/18/2006

Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format - 1/18/2006

Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format - 1/18/2006

Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products - Implementing the New Content and Format Requirements - 1/18/2006

Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - 1/11/2006

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 1/11/2006
    Appendix 2 (PDF - 1.2 MB)
    Appendix 3 - CDER MAPP 6020.3 (PDF - 22 KB), CBER SOPP 8405
    Appendix 4 (PDF - 2.5 MB)

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug and Biological Product Studies - 1/2006


2005

International Conference on Harmonisation (ICH): Q2(R1) Validation of Analytical Procedures: Text and Methodology
Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined Q2 document. The contents of the two guidances were not revised.

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) - 11/30/2005

International Conference on Harmonisation (ICH); Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs - 10/19/2005

International Conference on Harmonisation (ICH); Guidance for Industry: S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals - 10/19/2005

International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD - 10/18/2005

International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports - 9/30/2005

Draft Guidance for Industry: Using Electronic Means to Distribute Certain Product Information - 9/29/2005

Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials - 9/19/2005

Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection 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 - 9/15/2005 - (PDF - 84 KB)

Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act - 9/7/2005

International Conference on Harmonisation (ICH); Draft Guideline: M5 Data Elements and Standards for Drug Dictionaries - 9/2/2005

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 - 7/19/2005

FEDERAL REGISTER: Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection; Withdrawal of Guidance - 6/30/2005 - (PDF - 48 KB)

International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process - 6/29/2005

FEDERAL REGISTER: Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance - 6/28/2005 - (PDF - 50 KB)

Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection - 6/23/2005

Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients - 5/18/2005

Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - 5/12/2005

Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies - 4/27/2005

Guidance for Industry and FDA Staff: Application User Fees for Combination Products - 4/20/2005 - (PDF - 602 KB)

Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling - 4/20/2005

Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product - 4/11/2005 - (PDF - 73 KB)

International Conference on Harmonisation (ICH); Guidance for Industry: E2E Pharmacovigilance Planning - 3/31/2005

Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products - 3/30/2005

Guidance for Industry: Premarketing Risk Assessment - 3/25/2005

Guidance for Industry: Development and Use of Risk Minimization Action Plans - 3/25/2005

Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment - 3/25/2005

International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests - 3/11/2005

International Conference on Harmonisation (ICH) Guidance for Industry: E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 2) - 3/9/2005

FEDERAL REGISTER: Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance - 3/9/2005 (PDF - 51 KB)

Draft Guidance for Industry: Clinical Lactation Studies - Study Design, Data Analysis, and Recommendations for Labeling - 2/7/2005

Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees - 1/3/2005


2004

International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD -- Efficacy: Questions and Answers (Revision 3) - 12/22/2004
Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format

International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- General: Questions and Answers (Revision 3) - 12/22/2004

Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use - 11/30/2004 - (PDF- 345 KB)

Guidance for Industry: Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992; Notice of extension of application deadline - 11/19/2004 - (PDF - 54 KB)

Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA - 11/17/2004

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) - 11/12/2004

Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes - 10/28/2004

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 - 10/21/2004

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 - 10/1/2004 - (PDF - 114 KB)

Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information - 10/1/2004

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing -- Current Good Manufacturing Practice - 9/29/2004 -

Draft Guidance for Industry and FDA: Current Good Manufacturing Practice for Combination Products - 9/29/2004 - (PDF - 134 KB)

FEDERAL REGISTER - Annual Guidance Agenda - 9/23/2004 - (PDF - 154 KB)

Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct - 9/2/2004

Guidance on Research Involving Coded Private Information or Biological Specimens - 8/30/2004

Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols - 8/18/2004

Guidance for Industry: Available Therapy - 7/21/2004

Guidance for Industry: FDA Export Certificates - 7/12/2004
    (Corrected to update the Medical Devices contact phone number 4/27/2005)

Guidance for Industry: Developing Medical Imaging Drug and Biological Products - 6/17/2004

International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Quality: Questions and Answers/Location Issues - 6/8/2004

International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data - 6/7/2004

Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) - 5/28/2004 - (PDF - 440 KB)

Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - 5/20/2004 - (PDF - 373 KB)

Draft Guidance for Industry: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination - 3/8/2004

International Conference on Harmonisation (ICH); Guidance for Industry: Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs - 2/4/2004

Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices - 2/4/2004

Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements - 2/4/2004

Draft Guidance for Industry: "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms - 2/4/2004

Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1) - 1/26/2004

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revision 1) - 1/16/2004


2003

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Human Dura Mater - 12/17/2003

Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components - 12/09/2003

Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications - 11/21/2003 - (PDF -124 KB)

International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products - 11/20/2003

International Conference on Harmonisation (ICH); Guidance for Industry: Q3C - Tables and List - 11/12/2003

Guidance for Industry: Product Recalls, Including Removals and Corrections - 10/31/2003

Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review - 10/31/2003 - (PDF - 191 KB)

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus - 10/30/2003 - (PDF - 223 KB)

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations - 10/22/2003

Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - 10/8/2003

Guidance for Industry: Continuous Marketing Applications: Pilot 1 - Reviewable Units for Fast Track Products Under PDUFA - 10/6/2003

Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion - 9/22/2003

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 - 9/16/2003

ICH Draft Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting - 9/12/2003

Draft Guidance for Industry: Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information - 9/3/2003

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application - 9/3/2003

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug Applications and Abbreviated New Drug Applications - 8/27/2003

Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices - 7/24/2003

Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires - 7/3/2003

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 - 7/3/2003

Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis - 6/25/2003

Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations - 6/19/2003 - (PDF - 145 KB)

Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling - 5/30/2003

Guidance for Industry: Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications - 5/5/2003

Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review - 5/1/2003

FEDERAL REGISTER - Annual Guidance Agenda - 4/4/2003 - (PDF - 91 KB)

Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans - 4/3/2003

Draft Guidance for Industry; Comparability Protocols - Chemistry, Manufacturing, and Controls Information - 2/20/2003

Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews - 2/3/2003

International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Safety: Questions and Answers -2/3/2003

International Conference on Harmonisation (ICH); Guidance for Industry; Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products - 1/15/2003

Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers - 1/15/2003

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 VaccineRecipients - 12/30/2002 - (Corrected 2/4/2003)\


2002

The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry - 10/3/2002

Guidance for Industry: Establishing Pregnancy Exposure Registries - 9/20/2002 -

Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals - 9/6/2002

Guidance for Industry: Special Protocol Assessment - 5/16/2002

Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers - 5/13/2002

Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public - 5/2/2002 - HHS Guideline

Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs) - 3/26/2002

Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation - 3/8/2002

Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts - 2/1/2002

Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff - 1/11/2002


2001

Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act - 11/21/2001

Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees - 11/15/2001

Guidance for Industry - Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax - 10/17/2001

International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document - 10/16/2001 -

Guidance for Industry: Content and Format of Geriatric Labeling - 10/5/2001

Guidance for Industry: Cancer Drug and Biological Products - Clinical Data in Marketing Applications - 10/5/2001

International Conference on Harmonisation (ICH) Guidance; Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - 9/25/2001

Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format - General Considerations - 9/5/2001

Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research - 8/22/2001

Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - 8/22/2001

Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture - 8/7/2001

Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers - 7/19/2001

Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) - 7/19/2001

Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components - 7/19/2001

ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals - 7/12/2001

Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors - 7/11/2001

Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information - 5/25/2001

Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution - 5/14/2001

ICH Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials - 5/11/2001

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing - 3/29/2001

Guidance for Industry: Financial Disclosure by Clinical Investigators - 3/28/2001

Guidance for Industry: Acceptance of Foreign Clinical Studies - 3/13/2001

Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines - 3/12/2001

Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 - 2/13/2001

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Prescription Drug Advertising and Promotional Labeling - 1/31/2001

Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion - 1/23/2001

PHS Guideline on Infectious Disease Issues in Xenotransplantation - 1/19/2001


2000

International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances - 12/29/2000 - (PDF - 393 KB)

International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population - 12/15/2000

Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) - 12/4/2000

Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices - 11/22/2000

Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - 11/20/2000

Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts - 11/20/2000

Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds - 10/26/2000

Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products - 10/3/2000

Draft Guidance for Industry: Analytical Procedures and Methods Validation - Chemistry, Manufacturing, and Controls Documentation - 8/30/2000

International Conference on Harmonisation: (ICH); Draft Guidance: E12A Principles for Clinical Evaluation of New Antihypertensive Drugs - 8/2000

Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings - 7/22/2000

Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens - 6/23/2000

Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request - 6/21/2000

Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria - 6/8/2000

Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products - 3/7/2000

Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level - 3/7/2000

International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use - 2/10/2000


1999

Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 - 12/14/1999

Guidance for Industry: In Vivo Drug Metabolism / Drug Interaction Studies - Study Design, Data Analysis and Recommendations for Dosing and Labeling - 11/24/1999

REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)] - 11/12/1999, REVISED 11/22/1999

Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act - 10/8/1999

Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications - 9/13/1999

Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products - 8/27/1999

ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products - 8/18/1999 - (PDF - 58 KB)

Guidance for Industry: Consumer-Directed Broadcast Advertisements - 8/6/1999

Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations - 7/24/1999

Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) - 7/15/1999

ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability - 6/25/1999 - (PDF - 22 KB)

Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use - 5/20/1999

Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products - 5/20/1999

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" - 5/10/1999

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 -4/23/1999

Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans - 4/6/1999

Draft Guidance for Industry: Accelerated Approval Products - Submission of Promotional Materials - 3/26/1999

Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional Labeling - 3/12/1999

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product -3/8/1999

Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products - 2/17/1999

Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA) - 2/17/1999

Guidance for Industry: Population Pharmacokinetics - 2/10/1999

Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products - 2/3/1999

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product - 1/5/1999


1998

Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products - 11/30/1998

Guidance for Industry; Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 - 10/30/1998

Draft Guidance for Industry: Submitting Debarment Certification Statements -10/2/1998

ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin - 9/24/1998 - (PDF - 89 KB)

ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products - 9/21/1998 - (PDF - 47 KB)

ICH Guidance on Statistical Principles for Clinical Trials -9/16/1998 - (PDF - 108 KB)

Withdrawal of "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)" - Information Sheet - 9/8/1998

Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1) - 9/8/1998 - (PDF - 62 KB)

Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications -7/27/1998

Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements -7/21/1998

Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing -6/11/1998

ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data -6/10/1998 - (PDF - 90 KB)

Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products - 5/15/1998

Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements - 5/15/1998

Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis and Impact on Dosing and Labeling - 5/15/1998

Guidance for Industry: Classifying Resubmissions in Response to Action Letters -5/14/1998

Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients - 4/17/1998

Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy - 3/30/1998 - (PDF - 78 KB)

International Conference on Harmonisation (ICH); E2B Guidance on Data Elements for Transmission of Individual Case Safety Reports (PDF) 1/15/1998

Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products - 1/8/1998


1997

Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS) - 12/1997

International Conference on Harmonisation: (ICH); Guidance: E8 General Considerations for Clinical Trials (PDF) - 12/1997

Final Guidance on Industry: Supported Scientific and Educational Activities; Notice - 12/3/1997 - (PDF - 534 KB)

Guidance for FDA and Industry: Direct Final Rule Procedures - 11/21/1997

Guidance for Industry: Industry-Supported Scientific and Educational Activities - 11/1997

Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use - 10/07/1997

Guidance for Industry - Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report - 8/27/1997

Guidance for Industry - Donor Screening for Antibodies to HTLV-II - 8/15/1997 - (PDF - 28 KB)

Guidance for Industry - Screening and Testing of Donors of Human Tissue Intended for Transplantation - 7/29/1997 - (PDF - 34 KB)

Guidance for Industry - Changes to an Approved Application: Biological Products - 7/24/1997

Guidance for Industry - Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products - 7/24/1997

International Conference on Harmonisation (ICH); Guidance for Industry: M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (PDF) - 7/1997

International Conference on Harmonisation: (ICH); Guidance for Industry: S1B Testing for Carcinogenicity of Pharmaceuticals (PDF) - 7/1997

International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R) Addendum to Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addition of a Limit Dose and Related Notes (PDF) - 7/1997

International Conference on Harmonisation: (ICH); Guidance for Industry: S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF) - 7/1997

International Conference on Harmonisation (ICH); Guidelines for the Photostability Testing of New Drug Substances and Products - 5/16/1997 - (PDF - 59 KB)

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies - 4/10/1997 - (PDF - 49 KB)

Proposed Approach to Regulation of Cellular and Tissue-Based Products - 2/28/1997 - (PDF - 432 KB)

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use - 2/28/1997
(PDF - 140 KB)

Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products - 1/10/1997


1996

International Conference on Harmonisation (ICH); Guidance for Industry: Q1C Stability Testing for New Dosage Forms (PDF) - 11/1996

Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use - 8/1996 - (PDF - 44 KB)

International Conference on Harmonisation: Final Guidance on Stability Testing of Biotechnological / Biological Products - 7/10/1996 - (PDF - 26 KB)

International Conference on Harmonisation (ICH); ICH E3 - Guideline for Industry: Structure and Content of Clinical Study Reports (PDF - 466 KB) - 7/1996

International Conference on Harmonisation (ICH); Guideline for Industry: E4 Dose-Response Information to Support Drug Registration (PDF) - 7/1996

Guidance for Industry-The Content and Format for Pediatric Use Supplements - 5/1996 - (PDF - 21 KB)

Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Structural Repair or Reconstruction - 5/1996 - (PDF - 28 KB)

FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products - 4/1996 - (PDF - 25 KB)

International Conference on Harmonisation (ICH); Guidance for Industry: E6 Good Clinical Practice: Consolidated Guideline (PDF) - 4/1996

International Conference on Harmonisation (ICH); Guideline for Industry: S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility (PDF) - 4/1996

International Conference on Harmonisation: Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals - 3/1996

International Conference on Harmonisation: Final Guideline on Quality of Biotechnical Products: Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products - 2/1996

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1995 and earlier

Guideline for Quality Assurance in Blood Establishments - 7/11/1995
(NOTE: The text version does not contain Tables 1-8) - (PDF - 76 KB)

FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of Biological Products - 7/11/1995

Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals - 1995

International Conference on Harmonisation: (ICH); Guideline for Industry: E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (PDF) - 3/1995

International Conference on Harmonisation: (ICH); Guideline for Industry: E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF) - 3/1995

International Conference on Harmonisation: (ICH); Guideline for Industry: S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF) - 3/1995

International Conference on Harmonisation: (ICH); Guideline for Industry: S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF) - 3/1995

International Conference on Harmonisation: (ICH); Guideline for Industry: S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF) - 3/1995

Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products - 11/1994

International Conference on Harmonisation (ICH); Guideline for Industry: S5A Detection of Toxicity to Reproduction for Medicinal Products (PDF) - 9/1994

International Conference on Harmonisation (ICH); Guideline for Industry: E7 Studies in Support of Special Populations: Geriatrics (PDF) - 8/1994

Guidance on Alternatives to Lot Release for Licensed Biological Products - 7/14/1993

Draft Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993) - 7/12/1993

Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologics Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability - 4/6/1992

Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin - 1992

Draft Recommended Methods for Blood Grouping Reagents Evaluation - 3/1992

Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin - 3/1992

Guideline for the Determination of Residual Moisture in Dried Biological Products - 1/1/1990

Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors) - 10/26/1989

Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononeuclear Leukocytes for Administering to Humans - 8/22/1989

Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1 - 8/8/1989

Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices - 12/1987

Guideline on General Principles of Process Validation - 5/1987

Guideline for the Uniform Labeling of Blood and Blood Components - 8/1985

Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology - 4/10/1985

Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans - 7/28/1983

Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances - 6/1980

 
Updated: January 16, 2009