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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Biological Approvals by Year

The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities. The annual biological approvals are broken into lists based on these regulatory authorities. See the Development and Approval Process page for a description of what types of products are regulated at Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510(k)s.  

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Approvals & Clearances

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002
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