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, USDA, and EPA jurisdiction over product areas and delve into agency enforcement tools to ensure compliance; identify and address ambiguities and challenges surrounding the realm of animal drugs, food, and feed; and shed light upon innovations in the field of veterinary products.
Agenda Highlights
- Provide foundation of relevant laws and regulations relating to regulation of veterinary products
- Illustrate differences between human and veterinary medical product approval lifecycles
- Clarify jurisdictional boundaries between FDA, USDA, and EPA on veterinary product regulation and enforcement
- Discuss FDA center collaborations related to veterinary products
- Explain animal drug, food & feed regulatory requirements and discuss recent developments, as well as challenges in labeling, advertising, and inspections
- Explore veterinary product innovations, including testing alternatives and new medical technologies
Statutes Covered
- Laws
- 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
- the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
- the Minor Use and Minor Species Animal Health Act (MUMS)
- Animal Welfare Act
- FDA Regulations Related to Vet Products (CFR Title 21)
- part 200 (Labeling)
- part 225 – CGMPs for Medicated Feeds
- part 226 – CGMPs for Medicated Articles
- Chapter 1, Subchapter E (Animal Drugs, Feeds, and Related Products)
- part 1240 (Control of Communicable Diseases)
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
Register by December 31!
Firms, Sole,
Consultants
- +$100 for non-members
- +$50 after 12/31/2023
- +$150 after 1/31/2024
Industry/ Manufacturer
- +$100 for non-members
- +$50 after 12/31/2023
- +$150 after 1/31/2024
Government
- +$100 for non-members
- +$50 after 12/31/2023
- +$150 after 1/31/2024
Nonprofit & Academic
- +$100 for non-members
- +$50 after 12/31/2023
- +$150 after 1/31/2024
Student
- students registration
- full-time students only
- transcript required
Add This Must-Have Reference to Your Registration Purchase
Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.
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