2020 - The Veterinary Drug Approval Process and FDA Regulatory Oversight

Upon completing this course on veterinary medicine regulations participants will:
Understand how the U.S. Food and Drug Administration regulates veterinary drug product.
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 an NADA.
Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness.
Gain general understanding of FDA’s rules governing chemistry, manufacturing and controls (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.
Explore problem solving methods to mitigate regulatory enforcement risks.
Explain how jurisdiction is split between various Federal agencies in a certain cases.
Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S.