Event

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. In this two-day interactive online seminar, Senior Counsel Karl Nobert will provide attendees with an understanding of FDA’s veterinary drug approval process, the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly cover animal products that are regulated by other federal agencies.

Key goals of the seminar will include learning:

• How the U.S. Food and Drug Administration (FDA) regulates animal drug products.
• How FDA’s Center for Veterinary Medicine is organized.
• The process by which veterinary drug products are reviewed and approved.
• How to open an Investigational New Animal Drug (INAD) File.
• The FDA’s various user fees, what fee waivers are available, and how to request a fee waiver.
• The various technical sections included in a New Animal Drug Application (NADA).
• What information is needed to substantiate product characterization, target animal safety and effectiveness.
• An overview of FDA’s rules governing chemistry, manufacturing and controls (CMC).
• The various components of an animal field study to support product approval.
• How animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.