About FDA
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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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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) Postmarketing 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) Recalls (Biologics) Warning Letters Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics BIMO/Team Biologics/Internet Surveillance/Other
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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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Contact FDA
(800) 835-4709
(301) 827-1800
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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