CBER Guidances / Guidelines / Points to Consider
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Proposed/Final Rules
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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International Conference on Harmonisation (ICH); Draft Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals - 9/4/2008
Draft Guidance for Industry: Integrated Summary of Effectiveness - 8/27/2008
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and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Draft Guidance for the Public and FDA Staff: Convening Advisory Committee Meetings (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial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International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for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International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4C: Microbiological Examination of Non-Sterile Products: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
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
- International Conference on Harmonisation (ICH); Guidance for Industry - Q8 Pharmaceutical Development - 5/19/2006
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: Pharmacogenomic Data Submissions - 3/22/2005
- Attachment to Guidance on Pharmacogenomic Data Submissions - 3/22/2005
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
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics - 7/20/2007
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: 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
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
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 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
- 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 - 1/9/2002
- 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"
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)
- FEDERAL REGISTER; Vaccine Adverse Event Reporting System; Revised Form VAERS-2; Availability - 11/20/2001 - (PDF - 41 KB)
- Draft Form (for comment) - (PDF - 85 KB), Instructions - (PDF - 14 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)
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.
- International Conference on Harmonisation: (ICH); Guideline for Industry: Q2A Text on Validation of Analytical Procedures (PDF) - 3/1995
- International Conference on Harmonisation (ICH); Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology (PDF - 44 KB) - 5/19/1997
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
- Companion Document: Current Q&As and Change Requests - (Updated) Version 1.14: November 1, 2007 (PDF - 276 KB) - 5/21/2008
- International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification - 4/1/2003
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
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: 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: 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 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
- Part 1: Conducting Safety Assessments
- Part 2: Clinical Indications
- Part 3: Design, Analysis, and Interpretation of Clinical Studies
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 and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices - 2/4/2004
- Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) - 2/4/2004
- 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 - 2/4/2004
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: 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: Providing Regulatory Submissions in Electronic Format - General Considerations - 1/28/1999
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion - 9/22/2003
- Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS - 4/17/2003
- Question and Answer on FDA Guidance Entitled "Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS"
- Since Publication of this guidance, CDC issued a health alert for travelers arriving from Toronto Canada, and updated their case definition. As discussed in the guidance under section II. B. 3., Updated Information on
Case Definitions in Areas Affected by SARS, the FDA indicated that you should consult with the CDC website and phone number for updates. Phone (888) 246-2675.
- Updated Interim U.S. Case Definition of Severe Acute Respiratory Syndrome (SARS). http://www.cdc.gov/ncidod/sars/casedefinition.htm
- Question and Answer on FDA Guidance Entitled "Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS"
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application - 9/3/2003
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices - 7/24/2003
Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations - 6/19/2003 - (PDF - 145 KB)
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)
Draft Guidance for Industry; Comparability Protocols - Chemistry, Manufacturing, and Controls Information - 2/20/2003
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)\
Guidance for Industry: Establishing Pregnancy Exposure Registries - 9/20/2002 -
Guidance for Industry: Special Protocol Assessment - 5/16/2002
Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public - 5/2/2002 - HHS Guideline
Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff - 1/11/2002
Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act - 11/21/2001
International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document - 10/16/2001 -
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M4: Organization of the CTD
M4E: The CTD - Efficacy
M4Q: The CTD - Quality
M4S: The CTD - Safety
M4S: The CTD - Safety Appendices
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
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - 8/22/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers - 7/19/2001
ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals - 7/12/2001
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
PHS Guideline on Infectious Disease Issues in Xenotransplantation - 1/19/2001
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)
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 and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings - 7/22/2000
Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request - 6/21/2000
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
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
ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability - 6/25/1999 - (PDF - 22 KB)
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products - 5/20/1999
Draft Guidance for Industry: Accelerated Approval Products - Submission of Promotional Materials - 3/26/1999
Guidance for Industry: Population Pharmacokinetics - 2/10/1999
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)
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
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: 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)
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 - 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
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 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)
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)
Guideline for Quality Assurance in Blood Establishments - 7/11/1995
(NOTE: The text version does not contain Tables 1-8) -
(PDF - 76 KB)
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
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 on General Principles of Process Validation - 5/1987
Guideline for the Uniform Labeling of Blood and Blood Components - 8/1985
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances - 6/1980