Introduction to Veterinary Products

Overview

Agenda

Details

Overview

This comprehensive course is tailored for professionals seeking to build a foundation in the growing field of veterinary products law and regulation. Sessions will offer an insightful perspective on the unique intricacies distinguishing human and veterinary medical product approval and lifecycles; clarify FDA and USDA jurisdiction over product areas; and identify and address ambiguities and challenges surrounding the realm of animal drugs, food, dietary supplements, and feed.

Agenda Highlights

• Provide foundation of relevant laws and regulations relating to veterinary products
• Illustrate differences between human and veterinary medical product approval lifecycles
• Clarify jurisdictional boundaries between FDA and USDA on veterinary product regulation and enforcement
• Explain animal drug, food and feed regulatory requirements and discuss recent developments and challenges

Statutes Covered

• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• the Animal Drug Availability Act (ADAA)
• the Animal Medicinal Drug Use Clarification Act (AMDUCA)
• the Animal Drug User Fee Act (ADUFA)
• the Animal Generic Drug User Fee Act (AGDUFA)
• the Food Safety Modernization Act (FSMA)
• the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
• the Minor Use and Minor Species Animal Health Act (MUMS)
• Animal Welfare Act (AWA)
• FDA Regulations Related to Vet Products (CFR Title 21)

Attendee Resources

• Access to an electronic copy of the FDCA Statutory Supplement, 2021 2nd Edition
• PDF copies available of instructor PowerPoint presentations

Who Should Attend

• New legal and regulatory professionals entering the veterinary products field
• Seasoned practitioners new to the topic or wanting a refresher

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