April 3-4, 2023

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 and monitoring of drugs intended for animals, including most cell-based animal drug products. CVM also has jurisdiction over animal feeds, pet food, food additives, pet treats and animal medical devices. However, FDA does not regulate all products intended for animal use. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and some flea and tick products are regulated by the Environmental Protection Agency.

This seminar on veterinary medicine regulations will provide attendees with an understanding of FDA’s veterinary drug approval process. This two-day interactive course will cover:

  • Premarket approval process
  • Various sections of a New Animal Drug Application
  • Strategies for navigating the FDA approval process.