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 pet/companion animals (e.g., dogs, cats, horses, etc.).

In addition to their management office, the Center for Veterinary Medicine is comprised of the following offices:

• Office of New Animal Drug Evaluation - The pre-marketing staff determine whether or not a drug should be approved for marketing. Pre-marketing reviewers study data submitted by drug sponsors to determine if submitted data are adequate to support a drug's approval for marketing.
  
  The Office of New Animal Drug Evaluation (ONADE) is comprised of the following divisions:
  • Division of Human Food Safety
  • Division of Production Drugs
  • Divisions of Therapeutic Drugs for Food Animals
  • Division of Scientific Support
  • Division of Manufacturing Technologies
  • Division of Therapeutic Drugs for Non-Food Animals
• Office of Surveillance and Compliance - Once approved products are on the market, the Center for Veterinary Medicine monitors the use of the products through surveillance and compliance programs. The post-marketing staff monitors marketed animal drugs, food additives, and devices to assure continuing safety and effectiveness. They also process legal cases brought against violators by the Center.
• Office of Research - The research staff in CVM conduct studies to support both pre- and post-marketing activities by providing information to aid CVM scientists in the review and decision-making processes. The Office of Research (OR) is comprised of the Divisions of Residue Chemistry, Animal Research and Animal and Food Microbiology.
• Office of Minor Use and Minor Species Animal Drug Development - The Office of Minor Use and Minor Species (OMUMS) Animal Drug Development is the smallest Office in the Center for Veterinary Medicine. Its mission is similar to that of the Office of Orphan Products for human drugs and devices. The Office designates qualified new animal drugs for specific minor uses, or for specific intended uses in minor species. (Minor animal species include animals other than the major species: cattle, swine, chickens, turkeys, horses, dogs, and cats.). Additionally, the Center for Veterinary Medicine (CVM) develops and issues many animal & veterinary guidance documents available for industry. For a listing and access to these documents, see the following link:
  http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

Research by Diane Meade