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Vaccines, Blood & Biologics
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Resources for You
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General Biologics Proposed and Final Rules
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
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General
- Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
8/21/2009 - Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date
8/21/2009 - Expanded Access to Investigational Drugs for Treatment Use, Final Rule (Federal Register)
8/13/2009 - Charging for Investigational Drugs Under an Investigational New Drug Application, Final Rule (Federal Register)
8/13/2009 - FDA Regulations; Technical Amendment; Correction
9/19/2008 - FDA Regulations; Technical Amendment
8/25/2008 - Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
8/8/2007 - Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Technical Amendment
3/24/2005 - Revision of the Requirements for Spore-Forming Microorganisms; Confirmation of Effective Date
5/14/2004 - Revision of the Requirements for Spore-Forming Microorganisms
12/30/2003 - Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule
12/30/2003 - New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval; Technical Amendment
6/11/2003 - Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule
3/14/2003 - Revision to the General Safety Requirements for Biological Products
3/4/2003 - Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Delay of Effective Date
2/20/2001 - Biological Products: Reporting of Biological Product Deviations in Manufacturing
11/9/2000 - Biological Products: Reporting of Biological Product Deviations in Manufacturing (Final Rule)
11/7/2000 - Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment
10/6/2000 - Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Technical Amendment
8/29/2000 - Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License
10/20/1999 - Revisions to the General Safety Test Requirements for Biological Products
8/5/1998 - Revisions to the General Safety Requirements for Biological Products
4/20/1998
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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