The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the
Food and Drug Administration, which is in the
United States Department of Health and Human Services. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biological and related products, including:
Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities.Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels.
Vaccines for use in humans.Allergenic extracts.Some medical devices, specifically test kits for
HIV, tests used to screen blood donations, and blood bank computer software.
Xenotransplantation.
Gene therapy and
Human Cloning.Historically, CBER was responsible for some medications, such as antisera and antitoxins. Control of some of these has been transferred to CDER.
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Center for Biologics Evaluation and Research (USA) Division of the FDA that regulates biological products, including the blood supply and products derived from it, vaccines, human tissue for transplantation, allergenic materials and anti-toxins, and biological therapeutics. (Find more detail in the iFDA to Consolidatei box.).