Vaccines, Blood & Biologics
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General Biologics, Notices, Proposed and Final Rules
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Notices
- Federal Register Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications
7/31/2012 - Federal Register Notice: Guidance for Industry: Lupus Nephritis Caused By Systemic Lupus Erythematosus — Developing Medical Products for Treatment; Notice; withdrawal.
6/2010. (This guidance has been withdrawn) - Federal Register Notice: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies
2/18/2012 - Federal Register Notice: Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease
11/16/2011 - Federal Register Notice: Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Staff; Decisions for Investigational Device Exemption Clinical Investigations; Availability
11/10/2011 - Federal Register Notice: Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format
10/12/2011 Request for Notification for Nominations for a Nonvoting Industry Representative on the Vaccines and Biological Products Advisory Committee
9/29/2011Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
9/27/2011Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease
9/26/2011Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
8/29/2011- Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments (Federal Register Notice PDF, 8/4/2011)
8/4/2011 Guidance for Industry on Process Validation: General Principles and Practices; Availability
1/25/20112010 FDA Guidance Agenda
12/7/2010Reclassification of Category IIIA Biological Products, Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Final Order;
12/6/2010Guidance for Industry: Recommendations for Blood Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application
12/3/2010Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation
9/7/2010International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions
4/12/2010
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Proposal Rules
Proposed Rule: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
2/25/2013- Proposed Rule: Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner
1/27/2012 Proposed Rule - Amendments to Sterility Test Requirements for Biological Products, June 21, 2011
6/21/2011Disqualification of a Clinical Investigator; Proposed Rule (Federal Register)
4/13/2011Proposed Rule - Revision of the Requirements for Constituent Materials
3/30/2010Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner.
3/29/2010Proposed Rule - Reporting Information Regarding Falsification of Data (Feb. 19, 2010)
2/19/2010Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
8/21/2009Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule (Federal Register)
1/12/2007Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule
12/30/2003Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule
3/14/2003
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Final Rules
Use of Certain Symbols in Labeling
4/19/2013- Final Rule - Current Good Manufacturing Practice Requirements for Combination Products
1/22/2013 - Final Rule - Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002..
8/2/2012 - Final Rule - Amendments to Sterility Test Requirements for Biological Products; Correction
5/24/2012 - Final Rule - Amendments to Sterility Test Requirements for Biological Products
5/3/2012 Final Rule - Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
2/6/2012- Final Rule - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment (Final rule; technical amendment)
6/24/2011 Final Rule - Revision of the Requirements for Constituent Materials
4/13/2011Final Rule - Revision of Organization and Conforming Changes to Regulations
4/1/2010Final Rule - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment.
4/1/2010Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date
8/21/2009Expanded Access to Investigational Drugs for Treatment Use, Final Rule (Federal Register)
8/13/2009Charging for Investigational Drugs Under an Investigational New Drug Application, Final Rule (Federal Register)
8/13/2009FDA Regulations; Technical Amendment; Correction
9/19/2008Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
9/8/2008FDA Regulations; Technical Amendment
8/25/2008- Final Rule - Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials
7/15/2008 Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
8/8/2007Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Technical Amendment
3/24/2005Revision of the Requirements for Spore-Forming Microorganisms; Confirmation of Effective Date
5/14/2004Revision of the Requirements for Spore-Forming Microorganisms
12/30/2003New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval; Technical Amendment
6/11/2003Revision to the General Safety Requirements for Biological Products
3/4/2003Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Delay of Effective Date
2/20/2001Biological Products: Reporting of Biological Product Deviations in Manufacturing
11/9/2000Biological Products: Reporting of Biological Product Deviations in Manufacturing (Final Rule)
11/7/2000Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment
10/6/2000Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Technical Amendment
8/29/2000Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License
10/20/1999Revisions to the General Safety Test Requirements for Biological Products
8/5/1998Revisions to the General Safety Requirements for Biological Products
4/20/1998
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