The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval and monitoring of drugs intended for animals, including most cell-based animal drug products. CVM also has jurisdiction over animal feeds, pet food, food additives, pet treats and animal medical devices. However, FDA does not regulate all products intended for animal use. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and some flea and tick products are regulated by the Environmental Protection Agency.
This seminar on veterinary medicine regulations will provide attendees with an understanding of FDA’s veterinary drug approval process. This two-day interactive course will cover:
- Premarket approval process
- Various sections of a New Animal Drug Application
- Strategies for navigating the FDA approval process
Learning Objectives:
Upon completing this course on veterinary medicine regulations participants will:
- Understand how the U.S. Food and Drug Administration (FDA) regulates veterinary drug products.
- Understand how FDA’s Center for Veterinary Medicine (CVM) 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 New Animal Drug Application (NADA).
- Develop a deep understanding of what data is needed to support 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.
- Learn how animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.
Who will Benefit:
This course is designed for people tasked with developing an animal health company’s product portfolio and responsible for overseeing a company’s regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, evaluating new technologies or applications, and those tasked with ensuring corporate compliance. Among others, this includes:
- Personnel new to the Animal Health Industry
- CRO professionals
- Entrepreneurs looking to add value to their products
- Regulatory professionals
- Compliance professionals
- U.S. Agents of Foreign Corporations
- Legal Professionals
- Financial Advisors and Institutional Investors
- Consultants, Inspectors and cGxP Experts
- Introduction to the Veterinary Drug Approval Process
- Definitions
- Overview of typical steps in veterinary drug development
- INAD/NADA technical sections
- Some differences between human and animal drug approval process
- FDA organization and jurisdiction
- FDA Centers relevant to Animal Health
- Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
- FDA Guidance documents and other online resources
- INAD/NADA Phased Review
- Open an INAD File
- Submit Early Information
- Phased Review of Technical Sections
- Meetings with CVM
- Brief description of cGxP (GMP, GLP, GCP)
- Developing the NADA Technical Sections
- Chemistry, Manufacturing, Controls (CMC)
- Product Characterization (required for stem cells and other cell-based products only)
- Effectiveness – planning and conducting clinical field studies
- Target Animal Safety (TAS)
- Human Food Safety
- Environmental Impact
- Labeling
- Freedom of Information (FOI) Summary
- All Other Information (AOI)
- Overview of Generic Animal Drugs (JINAD)
- CMC
- Bioequivalence (Safety & Efficacy)
- Human Food Safety
- Labeling
- Minor Use Minor Species (MUMS)
- Designation
- Determination
- Indexing
- Marketing Exclusivity & Exclusive Marketing Rights
- Animal Drug User Fees and related waivers
- Animal Feed, OTC Drugs, Supplements, Medical Devices
- USDA & EPA
- Non-Approval-Related Considerations
- Extra-Label Drug Use
- Compounding
- Noncompliance and Enforcement
- Pharmacovigilance
- Post-approval submissions for CMC changes
Mark Hughes
Consultant, Hughes Veterinary Consulting
Dr. Mark Hughes, DVM, MS, has over 13 years of experience in veterinary drug product development and over 20 years of experience in university veterinary research, laboratory animal medicine, and development of in-vitro diagnostic tests. He has managed or contributed to clinical studies and regulatory submissions on the safety and effectiveness of veterinary drugs (including stem cells) for therapeutic treatments related to dermatology, cardiology, endocrinology, oncology, osteoarthritis, and infectious diseases. Through his part-time consulting business, Hughes Veterinary Consulting, he assists domestic and international biotech and pharmaceutical companies with the process of applying for regulatory approval of drug products for use in companion animals.
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