Center for Biologics Evaluation and Research (CBER)


The FDA successor to the Bureau of Biologics concerned with biologic drugs and with the new protein and peptide drugs arising from biotechnology. According to its charter, CBER is responsible for ensuring: The safety of the U.S. entire blood supply and the products derived from it. The production and approval of safe and effective childhood vaccines, including any future AIDS vaccines. The proper oversight of human tissue for transplantation. An adequate and safe supply of allergenic materials and anti-toxins. The safety and efficacy of biological therapeutics, including an exciting new array of biotechnology-derived products used to treat diseases such as cancer and AIDS.

FDA definition updated 1/30/22:
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

CBER 2021-2025 Strategic Plan

About CBER
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