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GUIDANCE DOCUMENTS (2008 - 2000)

2008

Date Issued	Title	Pages	Doc (.pdf)
9/17/08	International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies	13
9/9/08	Concept Paper: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule	17
9/8/08	Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases	11
9/4/08	M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals	28
8/27/08	Draft Guidance for Industry on Integrated Summary of Effectiveness	16
8/07/08	Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers	23
8/07/08	Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees	25
8/07/08	Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers	14
8/07/08	Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings	6
8/07/08	Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members	20
8/07/08	Draft Guidance for the Public and FDA Staff: Convening Advisory Committee Meetings	6
8/07/08	International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter	4
8/07/08	International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter	4
8/07/08	International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter	4
8/07/08	International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter	6
8/05/08	International Conference on Harmonisation (ICH); Draft Guideline: E2F Development Safety Update Report	34
8/05/08	Draft Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes	9
7/30/08	Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products	7
7/29/08	Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions -Statement of Investigator (Form FDA 1572)	13
7/17/08	Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency	17
7/15/08	CGMP for Phase 1 Investigational Drugs Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials (21 CFR Part 210)	20 11
6/17/08	Guidance for Industry: Indexing Structured Product Labeling (Revision 1)	9
6/11/08	Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports	11
6/11/08	Providing Regulatory Submissions in Electronic Format - Postmarketing Individual Case Safety Reports	11
6/5/08	International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances	17
5/30/08	Guidance for Industry: Indexing Structured Product Labeling	9
5/21/08	Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products	14
5/20/08	Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)	10
4/28/08	Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application	17
4/25/08	Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)	14
4/21/08	Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007	4
4/16/08	Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests	10
4/09/08	Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)	39
4/09/08	Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)	44
4/07/08	International Conference on Harmonisation (ICH); Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories	10
3/25/08	S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use	38
3/07/08	Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements	14
3/07/08	Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices	15
2/22/08	Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products	9
2/21/08	ICHQ4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 1: Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)	14 6
2/11/08	Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products	14
1/10/08	International Conference on Harmonisation (ICH); Draft Guidance: Q8(R1) Pharmaceutical Development Revision 1 ICH Q8 Pharmaceutical Development (5/19/06)	16
1/11/08	FDA Licenses 14 New Blood-Typing Tests: New tests help assure safe transfusions	1

2007

Date Issued	Title	Pages	Doc (.pdf)
12/31/07	Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements	14
12/17/07	Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods	34
12/14/07	Draft ICH Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter	4 7
11/29/07	Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle	8
11/27/07	Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols	8
11/21/07	Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAG) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes	6
11/1/07	Draft Guidance for the Public, FDA Advisory Committee and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information Waivers	12
10/29/07	Draft Guidance for Industry and FDA Staff: Invitro Diagnostic (IVD) Device Studies - Frequently Asked Questions	49
10/29/07	Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications	13
10/26/07	Guidance for Industry: Blood Establishment Computer System Validation in User's Facility	11
10/24/07	Guidance for Industry: Drug Induced Liver Damage - Premarketing Clinical Evaluation	26
10/24/07	Guidance for Industry, FDA and Foreign Governments: FY 2008 Medical Device User Fee Small Business Qualification and Certification	34
10/18/07	Federal Register/Vol. 72, No. 201 / Rules and Regulations	4
10/18/07	Federal Register/Vol. 72, No. 201 / Proposed Rules	4
9/27/07	Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials	10
9/14/07	Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions	13
9/6/07	Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms	17
8/28/07	Draft Guidance for Industry: Pharmacogenomic Data Submissions - Companion Guidance	28
8/24/07	Guidance for Industry: Pharmacogenomic Data Submissions - Companion Guidance	28
8/24/07	Guidance for Industry: Regulation of Human Cells, Tissues and Cellular and Tissue Based Products (HCTP/s) Small Entity Compliance Guide	15
8/24/07	Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV	20
8/8/07	Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay	29
8/7/07	Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAG) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes	6
7/31/07	Guidance: Emergency Use Authorization of Medical Products	16
7/24/07	Guidance for Industry: Exports under the FDA Export Reform and Enhancement Act of 1996	61
7/24/07	Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays	15
7/23/07	Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)	7
7/23/07	Federal Register Vol.72, No.140/ Notices	3
7/20/07	Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics	17
7/12/07	International Conference on Harmonisation (ICH); Draft Guidance: Q10 Pharmaceutical Quality System	19
7/6/07	Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage	19
7/2/07	Draft Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document	10
6/22/07	Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission	17
6/20/07	Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs	9
6/20/07	Draft Guidance for Industry: "Computer Crossmatch" (Electronic Based Testing for the Compatability between the Donor's Cell Type and the Recipient's Serum or Plasma Type)	14
6/4/07	Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Receipt Date	9
5/31/07	Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines	20
5/31/07	Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines	17
5/15/07	Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics	22
5/10/07	Guidance for Industry: Computerized Systems Used in Clinical Investigations	13
5/10/07	Draft Guidance for Industry: Protecting the Rights, Safety and Welfare of Study Subjects - Supervisory Responsibility of Investigators	19
4/17/07	Draft Guidance for Clinical Investigators, Sponsors and IRBs Adverse Event Reporting - Improving Human Subject Protections	11
4/9/07	Draft Guidance for Industry: Dosage and Administration Section of Labeling for Human Presciption Drug and Biological Products - Content and Format	13
3/26/07	Draft Guidance for Industry and FDA Staff: Modifications to Devices Subject to Pre Market Approval (PMA) - The PMA Supplement Decision Making Process	32
2/27/07	Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members	19
2/27/07	Draft Guidance for Industry: Complimentary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration	17
	Comment to the Docket on the "Draft Guidance for Industry: Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration	1
2/27/07	Guidance for Industry: Eligibility Determination for Donors of Human Cells,Tissues, and Cellular and Tissue Based Products (HCT/Ps)	71
1/31/07	Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container	19
1/23/07	Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests	10
1/16/07	Draft Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies	49
1/8/07	ICH Draft Guidance E15 Terminology in Pharmacogenomics	8

2006

Date Issued	Title	Pages	Doc (.pdf)
11/28/06	Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events	25
11/28/06	Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow up of Patients in Clinical Trials Using Retroviral Vectors	15
10/27/06	Guidance for Industry: Implementation of Acceptable Full Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components	10
10/30/06	Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production	17
10/18/06	Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components	20
10/18/06	Guidance for Industry: Biological Product Deviation Report for Blood and Plasma Establishments	32
10/5/06	Guidance for Industry: Bar Code Label Requirements - Questions and Answers	13
9/29/06	Federal Register /Vol.71, No. 189/ September 29, 2006/ Notices	2
9/29/06	Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations	32
9/28/06	ICH E5 Ethnic Factors: Questions and Answers	10
9/28/06	Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases	52
9/22/06	Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels	5
9/22/06	United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128	90
9/11/06	Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling	55
9/8/06	Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) - Manufacturing Arrangements	5
9/7/06	Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors - Exception from Informed Consent Requirements for Emergency Research	30
9/2/06	Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update	7
9/1/06	Federal Register - Annual Guidance Agenda	12
8/29/06	Federal Register: Requirements for Foreign an Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Proposed Rule	83
8/8/06	Guidance for Industry: Amendment (Donor Deferal for Transfuion in France Since 1980) to "Guidance for Industry: Revised Preventative Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jacob Disease (CJD) and Variant Creutzfeldt-Jacob Disease (vCJD) by Blood and Blood Products"	6
8/8/06	Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G(IgG)	6
8/7/06	ICHQ4B Draft Guidance: Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)	7
8/7/06	ICHQ4B Draft Guidance: Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) Annex 1: Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)	4
7/06	ICH Q3B(R2) Impurities in New Drug Products	18
6/12/06	Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation (CBER) in Electronic Format - Lot Release Protocols	9
6/1/06	Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment	22
6/1/06	ICH Q9 Quality Risk Management	25
5/19/06	ICH Q8 Pharmaceutical Development	12
5/4/06	Guidance for Industry: Development of Preventative HIV Vaccines for Use in Pediatric Populations	9
4/27/06	Guidance for Industry: Bar Code Label Requirements - Questions and Answers	11
4/25/06	Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimans that are not Individually Identifiable	10
4/25/06	Draft Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs	9
4/19/06	Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications	20
ICH 4/12/06	Guidance for Industry: S8 Immunotoxicity Studies for Human Pharmaceuticals	16
3/28/06	Federal Register: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration	46
3/27/06	Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees	38
3/15/06	Guidance for Industry: Using a Centralizled IRB Review Process in Multicenter Clinical Trials	10
3/2/06	Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Infuenza Vaccines	17
3/2/06	Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines	14
2/15/06	Guidance for Industry: Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization of 1997	25
2/13/06	Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications	14
2/2/06	Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims	36
1/06	Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies	16
1/18/06	Guidance for Industry: Labeling for Human Prescription Drug and Biological Products - Implementing the New Content and Format Requirements	31
1/18/06	Guidance for Industry: Warning and Precautions Contraindications and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format	14
1/18/06	Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format	25
1/18/06	Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Produt - Content and Format	16
1/12/06	Draft Guidance for Industry: INDs - Approaches to Complying with cGMP During Phase 1	20
1/11/06	Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical cGMP	16
1/11/06	Guidance for Industry: Fast Track Drug Development Programs - Designation, Development and Application Review	25
	Appendix 2	9
	Appendix 3 CDER MAPP 6020.3	4