3-Day Virtual Seminar The Veterinary Drug Approval Process and FDA Regulatory Oversight

Seminar : 3-Day Virtual Seminar The Veterinary Drug Approval Process and FDA Regulatory Oversight When: Wednesday to Friday Jun 9 - Jun 11 , 2021 DAY 01(9:00 AM TO 1:00 PM PDT)

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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:
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.
Obtain a working knowledge of various sections included within a NADA.
Develop a deep understanding of what is needed to substantiate product characterization, target safety, and effectiveness.
Analyze FDA’s rules governing chemistry, manufacturing, and controls or CMC.
Understand the various components of an animal field study to support product approval.
Discuss the difference between FDA’s various user fees and fee waivers.
Identify the elements of an FDA compliant label.
Develop a corporate compliance strategy covering labeling, marketing, and advertising.