What is the Center for Biologics Evaluation and Research (CBER)?
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. What products does CBER regulate? CBER regulates an array of diverse and complex biological products, both investigational and licensed, including: • Allergenics Patch tests used to diagnose the causes of contact dermatitis. Extracts used to diagnose and treat rhinitis (“hay fever”), allergic sinusitis and conjunctivitis, and bee stings. • Blood Blood and blood components used for transfusion, such as red blood cells, plasma, and platelets. Pharmaceutical products made from blood, such as clotting factors and immunoglobuilns. • Devices Medical d
