Center for Biologics Evaluation and Research

The Center for Biologics Evaluation and Research (CBER) is the Center within the U.S. Food and Drug Administration (FDA) that regulates certain categories of biologics for human use. Biologics regulated by CBER include: cellular products, gene therapy, vaccines, allergenic extracts, antitoxins, antivenins, venoms, blood, blood components, and plasma derived products. Although most biologics are regulated by the CBER, monoclonal antibodies, therapeutic proteins, and immunomodulators fall under the Center for Drug Evaluation and Research’s (CDER’s) regulatory oversight.

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U.S. Food and Drug Administration (FDA): Center for Biologics Evaluation and Research (CBER) Responsibilities Questions and Answers
U.S. Food and Drug Administration (FDA): Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)
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NCATS Toolkit for Patient-Focused Therapy Development: Discovery of Therapeutic Approach