Veterinary Products 

FDA Center for Veterinary Medicine (CVM) 

The FDA’s Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of drugs and food additives that will be given to, or used on, animals from which human foods are derived (e.g., poultry, cattle, swine, etc.), as well as food additives, drugs, and devices for pets or companion animals (e.g., dogs, cats, horses, etc.). CVM does not regulate vaccines for animals. Animal vaccines are regulated by the U.S. Department of Agriculture.

The Center for Veterinary Medicine is comprised of the following offices, in addition to the Management Office and Office of the Director:

Office of New Animal Drug Evaluation – The Office of New Animal Drug Evaluation (ONADE) determines whether or not an animal drug should be approved for marketing. ONADE is divided into several divisions, each charged with the evaluation or oversight of different aspects of the new animal drug review process. Divisions within ONADE include the Division of Human Food Safety, Division of Production Drugs, Division of Therapeutic Drugs for Food Animals, Division of Scientific Support, Division of Manufacturing Technologies, and Division of Therapeutic Drugs for Non-Food Animals.

Office of Surveillance and Compliance – The Office of Surveillance and Compliance has primary responsibility for the following functions: compliance-related actions; post-approval monitoring; pharmacovigilance; and animal food and pet food safety. The Office of Surveillance and Compliance monitors the safety and effectiveness of approved animal drugs after they enter the market. The Office also is responsible for animal food safety programs including the approval of food additives, monitoring the safety of animal feed and administering the medicated feed program.

Office of Research – The Office of Research conducts applied research in support of animal derived food and animal health products. The Office of Research is comprised of the Divisions of Residue Chemistry, Applied Veterinary Research, and Animal and Food Microbiology. The Office of Research works with other organizations through Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Interagency Agreements, and Memoranda of Understanding.

Office of Minor Use and Minor Species Animal Drug Development – The Office of Minor Use and Minor Species Animal Drug Development designates qualified new animal drugs for specific minor uses or for specific intended uses in minor species (all species that are not major species) and major species (horses, cattle, pigs, dogs, cats, chickens, and turkeys). Minor use status makes a new animal drug intended for such use eligible for designation, for conditional approval, and for waivers from user fees.

The Center for Veterinary Medicine provides a list of guidance documents, available here.

Updated by Theresa Pipher, October 2020