CBER Guidances / Guidelines / Points to Consider
CBER's Guidance documents relating to the FDA Modernization Act of 1997 can also be found on our
FDAMA Guidances page. Because CBER also regulates a number of medical devices, reference is made to the
CDRH Guidance pertaining to FDAMA
2004
Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) - 11/8/2004 -(PDF)
Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes - 10/28/2004 -
(PDF),
(Text)
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 -
(PDF),
(Text)
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),
(Text)
Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information - 10/1/2004 -
(PDF),
(Text)
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing -- Current Good Manufacturing Practice - 9/29/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations - 9/29/2004 -
(PDF),
(Text)
Draft Guidance for Industry and FDA: Current Good Manufacturing Practice for Combination Products - 9/29/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Computerized Systems Used in Clinical Trials - 9/29/2004 -
(PDF),
(Text)
- Guidance for Industry: Computerized Systems Used in Clinical Trials -
5/10/1999 -
(Text)
Draft Guidance for Industry and FDA Staff: Application User Fees for Combination Products - 9/23/2004 -
(PDF)
FEDERAL REGISTER - Annual Guidance Agenda - 9/23/2004 -
(PDF)
International Conference on Harmonisation (ICH); S7B Guideline: Step 2 Revision: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals - 9/10/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Draft Guidance: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs - 9/10/2004 -
(PDF),
(Text)
Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct - 9/2/2004 -
(PDF),
(Text)
Guidance on Research Involving Coded Private Information or Biological Specimens - 8/30/2004 -
(PDF)
Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification - 8/20/2004 -
(PDF),
(Text)
Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols - 8/18/2004 -
(PDF),
(Text)
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 7/21/2004 -
(PDF),
(Text)
Appendix 2 (PDF)
Appendix 3 -
CDER MAPP 6020.3 (PDF),
CBER SOPP 8405(Text)
Appendix 4 (PDF)
Guidance for Industry: Available Therapy - 7/21/2004 -
(PDF),
(Text)
Guidance for Industry: FDA Export Certificates - 7/12/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV
- 7/2/2004 -
(PDF),
(Text)
Guidance for Industry: Developing Medical Imaging Drug and Biological Products - 6/17/2004
- Part 1: Conducting Safety Assessments - (PDF),
(Text)
- Part 2: Clinical Indications - (PDF),
(Text)
- Part 3: Design, Analysis, and Interpretation of Clinical Studies -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Quality: Questions and Answers/Location Issues - 6/8/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data
- 6/7/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data - Questions and Answers - 6/3/2004 -
(PDF),
(Text)
Draft 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 - 6/3/2004 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) - 5/28/2004 -
(PDF),
(Text)
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),
(Text)
Draft Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - 5/20/2004 -
(PDF),
(Text)
- Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance -
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD -- Efficacy: Questions and Answers (Revision 2) - 5/5/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- General: Questions and Answers (Revision 2) - 5/5/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 1) - 5/5/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Premarketing Risk Assessment - 5/4/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Development and Use of Risk Minimization Action Plans - 5/4/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment - 5/4/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Combination Products, Timeliness of Premarket Reviews, Dispute Resolution - 5/4/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components - 4/23/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Draft Guidance: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process - 3/29/2004 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Draft Guidance: E2E Pharmacovigilance Planning (PvP) - 3/29/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination - 3/8/2004 -
(PDF),
(Text)
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 -
(PDF),
(Text)
- International Conference on Harmonisation (ICH); Guidance for Industry: E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs - 11/1996 -
(PDF)
Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices - 2/4/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements 2/4/2004 -
(PDF),
(Text)
- Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) - 2/4/2004 -
(PDF)
- 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 -
(PDF)
Draft Guidance for Industry: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms - 2/4/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling - 2/2/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1) - 1/26/2004 -
(PDF),
(Text)
Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products
for the Treatment of Cancer (Revision 1) - 1/16/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Drug Substance - Chemistry, Manufacturing, and Controls Information - 1/6/2004 -
(PDF),
(Text)
2003
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Human Dura Mater - 12/17/2003 -
(PDF),
(Text)
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components - 12/09/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices - 11/21/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications - 11/21/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission - 11/21/2003 -
(PDF),
(Text)
-
Guidance for Industry and FDA: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products - 3/12/2003 -
(PDF)
International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products - 11/20/2003 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R) Impurities in New Drug Products - 11/13/2003 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: Q3C - Tables and List - 11/12/2003 -
(PDF),
(Text)
- Guidance for Industry: Q3C Impurities: Residual Solvents - 12/24/1997 -
(PDF),
(Text)
Draft Guidance for Industry: Pharmacogenomic Data Submissions - 11/03/2003 -
(PDF),
(Text)
Guidance for Industry: Product Recalls, Including Removals and Corrections - 10/31/2003 -
(PDF)
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review - 10/31/2003 -
(PDF),
(Text)
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),
(Text)
Draft Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use - 10/28/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations - 10/22/2003 -
(PDF),
(Text)
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations -
1/28/1999 -
(PDF),
(Text)
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
(PDF),
(Text)
Guidance for Industry: Continuous Marketing Applications: Pilot 1 - Reviewable Units for Fast Track Products Under PDUFA - 10/6/2003 -
(PDF),
(Text)
Guidance for Industry: Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA - 10/6/2003 -
(PDF),
(Text)
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion - 9/22/2003 - (PDF),
(Text)
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 -
(PDF),
(Text)
- 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 -
(PDF),
(Text)
ICH Draft Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting - 9/12/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information - 9/3/2003 -
(PDF),
(Text)
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application - 9/3/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - 9/3/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related Submissions - 8/28/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug Applications and Abbreviated New Drug Applications - 8/27/2003 -
(PDF)
FEDERAL REGISTER: Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma; Withdrawal of Draft Guidance - 8/22/2003 -
(PDF),
(Text)
- Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma - 11/26/1999 -
(PDF),
(Text)
Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) - 8/15/2003 -
(PDF),
(Text)
Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification - 8/1/2003 -
(PDF),
(Text)
Draft Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products - 7/28/2003 -
(PDF),
(Text)
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices - 7/24/2003 -
(PDF),
(Text)
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires - 7/3/2003 -
(PDF),
(Text)
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 - (PDF),
(Text)
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis - 6/25/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports - 6/23/2003 -
(PDF),
(Text)
Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations - 6/19/2003 - (PDF),
(Text)
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002 - Identification of Manufacturer of Medical Devices - 6/19/2003 -
(PDF),
(Text)
Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling - 5/30/2003 -
(PDF),
(Text)
Guidance for Industry: Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications - 5/5/2003 -
(PDF),
(Text)
Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection - 5/1/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review - 5/1/2003
(PDF),
(Text)
FEDERAL REGISTER - Annual Guidance Agenda - 4/4/2003 -
(PDF)
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans - 4/3/2003 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification - 4/1/2003 -
(PDF)
Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification - 3/12/2003 -
(PDF),
(Text)
Draft Guidance for Industry; Comparability Protocols - Chemistry, Manufacturing, and Controls Information - 2/20/2003 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances - 2/11/2003 -
(PDF),
(Text)
FEDERAL REGISTER: Withdrawal of Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records - 2/4/2003 -
(PDF),
(Text)
- Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records - 11/12/2002 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews - 2/3/2003 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Safety: Questions and Answers -
2/3/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls Information - 1/28/2003 -
(PDF),
(Text)
Draft Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials - 1/23/2003 -
(PDF),
(Text)
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 -
(PDF),
(Text)
Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers - 1/15/2003 -
(PDF),
(Text)
Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine
Recipients - 12/30/2002 - (Corrected 2/4/2003) -
(PDF),
(Text)
2002
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry - 10/3/2002 -
(PDF),
(Text)
Draft Guidance for Industry: Nonclinical Studies for Development of Pharmaceutical Excipients - 10/1/2002 -
(PDF),
(Text)
Guidance for Industry: Establishing Pregnancy Exposure Registries - 9/20/2002 -
(PDF),
(Text)
Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals - 9/6/2002 -
(PDF),
(Text) - Comment period extended to 2/7/2003
Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)- 6/14/2002 -
(PDF),
(Text)
Guidance for Industry: Special Protocol Assessment - 5/16/2002 -
(PDF),
(Text)
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers - 5/13/2002 -
(PDF)
-
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation - 7/7/1999 -
(PDF),
(Text)
Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public - 5/2/2002 - HHS Guideline
Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components and Source Plasma Donations - 4/10/2002 -
(PDF),
(Text)
Guidance for Industry: E2BM Data Elements for Transmission of Individual Case Safety Reports - 4/4/2002 -
(PDF)
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs) - 3/26/2002 -
(PDF),
(Text)
Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation - 3/8/2002 -
(PDF),
(Text)
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 -
(PDF),
(Text)
- 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 Contacts - 12/23/1999 -
(PDF),
(Text)
Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff - 1/11/2002 -
(PDF),
(Text)
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 -
(PDF),
(Text)
2001
Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act - 11/21/2001 -
(PDF),
(Text)
Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees - 11/15/2001 -
(PDF),
(Text)
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 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document - 10/16/2001 -
M4: Organization of the CTD - (PDF)
M4E: The CTD - Efficacy - (PDF)
M4Q: The CTD - Quality - (PDF)
M4S: The CTD - Safety - (PDF)
M4S: The CTD - Safety Appendices - (PDF)
Guidance for Industry: Content and Format of Geriatric Labeling - 10/5/2001 -
(PDF),
(Text)
Guidance for Industry: Cancer Drug and Biological Products - Clinical Data in Marketing Applications - 10/5/2001 -
(PDF),
(Text)
International Conference on Harmonisation (ICH) Guidance; Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - 9/25/2001 -
(PDF)
Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format - General Considerations - 9/5/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls - 8/28/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research - 8/22/2001 -
(PDF),
(Text)
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - 8/22/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 8/10/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - 8/10/2001 -
(PDF),
(Text)
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 -
(PDF),
(Text)
Draft Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments - 8/3/2001 -
(PDF),
(Text)
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers - 7/19/2001 -
(PDF),
(Text)
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) - 7/19/2001
(PDF),
(Text)
Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components - 7/19/2001 -
(PDF),
(Text)
ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals - 7/12/2001 -
(PDF),
(Text)
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 -
(PDF),
(Text)
Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From An Outside Supplier - 7/11/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Clinical Studies Section of Labeling for Prescription Drugs and
Biologics--Content and Format - 7/9/2001 -
(PDF),
(Text)
Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information - 5/25/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution - 5/14/2001 -
(PDF),
(Text)
ICH Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials - 5/11/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports - 5/3/2001 -
(PDF);
(Text)
Draft Guidance for Industry: Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 - 4/4/2001 -
(PDF),
(Text)
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing - 3/29/2001 -
(PDF)
(Text)
Guidance for Industry: Financial Disclosure by Clinical Investigators - 3/28/2001 -
(Text)
Guidance for Industry: Acceptance of Foreign Clinical Studies - 3/13/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines - 3/12/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees - 2/22/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research - 2/15/2001 -
(PDF),
(Text)
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 - 2/13/2001 -
(PDF),
(Text)
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Prescription Drug Advertising and Promotional Labeling - 1/31/2001
(PDF),
(Text)
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion - 1/23/2001 - (PDF),
(Text)
PHS Guideline on Infectious Disease Issues in Xenotransplantation - 1/19/2001 -
(PDF),
(Text)
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),
(Text)
International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population - 12/15/2000 -
(PDF),
(Text)
Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) - 12/4/2000 -
(PDF),
(Text)
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices - 11/22/2000 -
(PDF),
(Text)
Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - 11/20/2000 -
(PDF),
(Text)
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts - 11/20/2000 -
(PDF),
(Text)
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds - 10/26/2000 -
(PDF),
(Text)
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 - 10/18/2000 -
(PDF),
(Text)
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 -
(PDF),
(Text)
- Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products - 11/1995 -
(PDF)
Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications - 9/8/2000 -
(PDF),
(Text)
Draft Guidance for Industry: Analytical Procedures and Methods Validation - Chemistry, Manufacturing, and Controls Documentation - 8/30/2000 -
(PDF),
(Text)
FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration - 7/21/2000 -
(PDF),
(Text)
Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment - 6/28/2000 -
(PDF),
(Text)
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens - 6/23/2000 -
(PDF),
(Text)
Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request - 6/21/2000 -
(PDF),
(Text)
Draft Guidance for Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics - 6/21/2000 -
(PDF),
(Text)
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria - 6/8/2000 -
(PDF),
(Text)
Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components - 6/6/2000 -
(PDF),
(Text)
- Guidance for Industry: United States Industry Consensus Standard for the Uniform labeling of Blood and Blood Components Using ISBT 128 - 11/1999 -
(PDF)
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing - 3/15/2000 -
(PDF),
(Text)
FEDERAL REGISTER: Quarterly List of Guidance Documents at the Food and Drug Administration - 3/14/2000 -
(PDF),
(Text)
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products - 3/7/2000 -
(PDF),
(Text)
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level - 3/7/2000 -
(PDF),
(Text)
International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use - 2/10/2000 -
(PDF)
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 -
(PDF),
(Text)
Guidance for Industry: In Vivo Drug Metabolism / Drug Interaction Studies - Study Design, Data Analysis and Recommendations for Dosing and Labeling - 11/24/1999 -
(PDF),
(Text)
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 - (PDF)
- CBER Computer Assisted License Application (CALA) Questionnaire
(PDF),
(Text)
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act - 10/8/1999 -
(PDF),
(Text)
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications - 9/13/1999 -
(PDF),
(Text)
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products - 8/27/1999 -
(PDF),
(Text)
ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products - 8/18/1999 -
(PDF),
(Text)
Guidance for Industry: Consumer-Directed Broadcast Advertisements - 8/6/1999 -
(PDF),
(Text)
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics - 8/3/1999 -
(PDF),
(Text)
Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations - 7/24/1999 -
(PDF),
(Text)
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) - 7/15/1999 -
(PDF),
(Text)
ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability - 6/25/1999 -
(PDF),
(Text)
Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV) - 6/17/1999 -
(PDF),
(Text)
- FEDERAL REGISTER Notice of Availability - 6/22/1999 -
(PDF),
(Text)
Draft Reviewer Guidance: Evaluation of Human Pregnancy Outcome Data - 6/4/1999 -
(PDF)
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use - 5/20/1999 -
(PDF),
(Text)
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products - 5/20/1999 -
(PDF),
(Text)
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 -
(PDF),
(Text)
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 -
(PDF),
(Text)
Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans -
4/6/1999 -
(PDF),
(Text)
Draft Guidance for Industry: Accelerated Approval Products - Submission of Promotional Materials -
3/26/1999 -
(PDF),
(Text)
Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional Labeling -
3/12/1999 -
(PDF)
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 -
(PDF),
(Text)
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 -
(PDF),
(Text)
Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA) -
2/17/1999 -
(PDF)
(Text)
Guidance for Industry: Population Pharmacokinetics -
2/10/1999 -
(PDF),
(Text)
Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products -
2/3/1999 -
(PDF),
(Text)
Guidance on Amended Procedures for Advisory Panel Meetings -
1/26/1999 -
(PDF),
(Text)
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 -
(PDF),
(Text)
1998
Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products - 11/30/1998 -
(PDF),
(Text)
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 11/18/1998 -
(PDF)
Appendix 2 (PDF)
Appendix 3 -
CDER MAPP 6020.3 (PDF),
CBER SOPP 8405 (Text)
Appendix 4 (PDF)
Guidance for Industry; Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 - 10/30/1998 -
(PDF)
Draft Guidance for Industry: Submitting Debarment Certification Statements -
10/2/1998 -
(PDF)
ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin - 9/24/1998 -
(PDF),
(Text)
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),
(Text)
ICH Guidance on Statistical Principles for Clinical Trials -
9/16/1998 -
(PDF),
(Text)
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 -
(Text)
- Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV) - 3/20/1998 -
(PDF),
(Text)
Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1) - 9/8/1998 -
(PDF),
(Text)
Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications -
7/27/1998 -
(PDF)
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 -
(PDF)
Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 - 6/12/1998 -
(PDF),
(Text)
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing -
6/11/1998 -
(PDF),
(Text)
ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data -
6/10/1998 -
(PDF),
(Text)
Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products -
6/8/1998 -
(PDF)
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products -
5/15/1998 -
(PDF)
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements -
5/15/1998 -
(PDF)
Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis and Impact on Dosing and Labeling -
5/15/1998 -
(PDF)
Guidance for Industry: Classifying Resubmissions in Response to Action Letters -
5/14/1998 -
(PDF)
Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research -
5/13/1998 -
(PDF)
Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients -
4/17/1998 -
(PDF)
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy -
3/30/1998 -
(PDF),
(Text)
Comprehensive List of Current Guidance Documents at the Food and Drug Administration - 2/26/1998 -
(PDF),
(Text)
Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products - 1/28/1998 -
(PDF),
(Text)
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substance - 1/16/1998 -
(PDF)
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products - 1/8/1998 -
(PDF),
(Text)
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 -
(PDF)
Final Guidance on Industry-Supported Scientific and Educational Activities; Notice - 12/3/1997 -
(PDF)
(Text)
Guidance for FDA and Industry: Direct Final Rule Procedures - 11/21/1997 -
(PDF)
Guidance for Industry: Industry-Supported Scientific and Educational Activities - 11/1997 -
(PDF)
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 -
(Text)
Guidance for Industry - Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report - 8/27/1997 -
(PDF)
Guidance for Industry - Donor Screening for Antibodies to HTLV-II - 8/15/1997 -
(PDF),
(Text)
Guidance for Industry - Screening and Testing of Donors of Human Tissue Intended for Transplantation - 7/29/1997 -
(PDF),
(Text)
Guidance for Industry - Changes to an Approved Application: Biological Products - 7/24/1997 -
(PDF),
(Text)
Guidance for Industry - Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products - 7/24/1997 -
(PDF),
(Text)
International Conference on Harmonisation (ICH) Guidelines for the Photostability Testing of New Drug Substances and Products - 5/16/1997 -
(PDF),
(Text)
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies - 4/10/1997 -
(PDF),
(Text)
Proposed Approach to Regulation of Cellular and Tissue-Based Products - 2/28/1997 -
(PDF),
(Text)
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use - 2/28/1997
(PDF),
(Text)
Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software - 1/13/1997 -
(PDF),
(Text)
Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products - 1/10/1997 -
(Text)
1996
Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications - 12/27/1996
(PDF),
(Text)
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),
(Text)
International Conference on Harmonisation: Final Guidance on Stability Testing of Biotechnological / Biological Products - 7/10/1996 -
(PDF),
(Text)
Guidance for Industry-The Content and Format for Pediatric Use Supplements - 5/1996 -
(PDF),
(Text)
Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Structural Repair or Reconstruction - 5/1996 -
(PDF),
(Text)
FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products - 4/1996 -
(PDF),
(Text)
International Conference on Harmonisation: Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals - 3/1996 -
(Text)
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 -
(Text)
1995 and earlier
Draft Reviewers' Guide: Disease Associated Antibody Collection Program - 10/1/1995 -
(PDF)
Draft Reviewers' Guide: Informed Consent for Plasmapheresis / Immunization - 10/1/1995 -
(PDF)
Guideline for Quality Assurance in Blood Establishments - 7/11/1995
(NOTE: The text version does not contain Tables 1-8) -
(PDF),
(Text)
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of Biological Products - 7/11/1995 -
(Text)
Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals - 1995 -
(Text)
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products - 11/1994 -
(PDF)
OELPS, Draft Advertising and Promotional Labeling Staff Procedural Guidance Document - 8/1994 -
(PDF),
(Text)
Draft Guideline for the Validation of Blood Establishment Computer Systems - 9/28/1993 -
(PDF),
(Text)
Guidance on Alternatives to Lot Release for Licensed Biological Products - 7/14/1993
(PDF)
Draft Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993) - 7/12/1993 - (PDF)
FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics - 11/25/1992 - (PDF)
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 - (PDF)
Guideline for the Determination of Residual Moisture in Dried Biological Products - 1/1/1990 -
(PDF),
(Text)
Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononeuclear Leukocytes for Administering to Humans - 8/22/1989 -
(PDF)
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 -
(PDF)
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 -
Sections I through IV - (PDF)
Section V - (PDF)
Appendix B, C and D - (PDF)
Appendix E, part 1 - (PDF)
Appendix E, part 2 - (PDF)
Guideline on General Principles of Process Validation - 5/1987
(PDF)
Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology - 4/10/1985 -
(PDF),
(Text)
Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans - 7/28/1983 -
(PDF)
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances - 6/1980 -
(PDF)
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