Regional North America United States Government Executive Branch Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research
The Mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through regulation of biological products including blood, vaccines, therapeutics and related drugs and devices according to statutory authorities
Center for Biologics Evaluation & Research (CBER)
Protects and enhances the public health through regulation of biological products including blood, vaccines, therapeutics and related drugs and devices according to statutory authorities
Regulates allergenic products. Site links to Advisory Committee meeting schedule and allergenics policy guides.
Blood and Blood Products
The FDA is responsible for ensuring the safety of our nation's blood supply. The CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves.
The CBER regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. CBER also regulates all HIV test kits.
Licensed Product Information
Alphabetical list by the proper name of the product. Links to the approval letter, label and review documents files for each product.
The CBER currently regulates human tissue intended for transplantation. Examples of such tissues are bone, skin, corneas, ligament and tendon.
The Center regulates vaccine products. Vaccines undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Major sections are Flu Vaccine, Thimerosal, Anthrax, and Bovine Spongiform Encephalopathy, ("mad cow disease.")
Last update:December 10, 2011 at 9:35:06 UTC