What divisions of FDA regulate drug products?
The Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM) all play central roles in assuring that safe and effective drugs are available to the American public. Drugs are chemically synthesized, while biologics are derived from living sources such as humans, animals, and microorganisms. CVM regulates the manufacture and distribution of drugs that will be given to animals. There is also an Office of Combination Products that regulates products comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic products.
