The Veterinary Drug Approval Process and FDA Regulatory Oversight

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

This three-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

Topics: FDA veterinary drug approval process, center for veterinary medicine, new animal drug application, investigational new animal drug (INAD) file, animal disease diagnostic devices, veterinary medicine regulations, veterinary drug user fees, Agriculture’s Animal and Plant Health Inspection Service, APHIS, NADA, FDA’s rules governing chemistry, animal field study, FDA compliant label, labeling, marketing, advertising, animal feed, veterinary devices, OTC drug products, FDA's product centers, Center for Food Safety and Applied Nutrition (CFSAN), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Tobacco Products, Center for Veterinary Medicine (CVM), environmental Impact (EA/CE), container Closure System, stability, Veterinary Clinical Trials, Animal Drug User Fees and Related Fee Waivers, 21 USC, 303 and 307