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, blood bank collection machines and equipment, 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. Some other drugs, such as certain anticoagulants and plasma volume expanders remain under the control of CBER.