Learning Objectives:

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.