Seminar: 3-Day Virtual Seminar The Veterinary Drug Approval Process and FDA Regulatory Oversight When: Wednesday -Friday October 20 - October 22 , 2021, DAY 01- 03 (9:00 AM TO 1:00 PM)
The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, the FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices, and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency.
This seminar on veterinary medicine regulations will provide attendees with an understanding of the 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 and for expending product approval
The nature of shared jurisdiction over veterinary products in certain cases
Upon completing this course on veterinary medicine regulations participants will:
Understand how the U.S. Food and Drug Administration regulates veterinary drug products.
Understand how FDA’s Center for Veterinary Medicine is organized.
Discuss the process by which veterinary drug products are reviewed and approved.
Learn how to open an INAD File and request fee waivers.
Analyze FDA’s rules governing chemistry, manufacturing, and controls or CMC.
Develop a corporate compliance strategy covering labeling, marketing, and advertising.
Learn how animal feed, veterinary devices, OTC drug products, and nutritional supplements are regulated in the U.S.
Register soon because space is limited.
We hope you’re able to join us!