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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.
Learning Objectives: Learn how to open an INAD File and request fee waivers.
Understand how the U.S. Food and Drug Administration regulates veterinary drug products.
Analyze FDA’s rules governing chemistry, manufacturing, and controls or CMC.
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