Introduction to Veterinary Products
May 2, 2024 Virtual Course
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