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  1. Development & Approval Process (CBER)

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.  

Biological approvals older than 2 years are available on FDA Archive.


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