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About FDA
Biologics Electronic Reading Room (eFOI)
The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site. These documents are frequently requested by the public through the Freedom of Information Act.
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Policy Statements
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Product Approval Information
- Biologics Products & Establishments
- Licensed Biological Products with Supporting Documents
- Substantially Equivalent 510(k) Device Information
- Premarket Approvals (PMAs)
- New Drug Applications (NDAs)
- Postmarket Requirements and Commitments: Introduction
- Transfer of Therapeutic Products to the Center for Drug Evaluation and Research
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Compliance, Surveillance & Enforcement
- Compliance Actions (Biologics)
- Compliance Programs (CBER)
- Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters
- Recalls (Biologics)
- Warning Letters
- Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics
- BIMO/Team Biologics/Internet Surveillance/Other
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Product Safety & Availability
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Meetings
- Allergenic Products Advisory Committee
- Blood Products Advisory Committee
- Cellular, Tissue, and Gene Therapies Advisory Committee
- Transmissible Spongiform Encephalopathies Advisory Committee
- Vaccines and Related Biological Products Advisory Committee
- Workshops, Meetings & Conferences (Biologics)
- Transcripts & Minutes (Biologics)
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Additional Documents Available from FDA
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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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