The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, the FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices, and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency.
This seminar on veterinary medicine regulations will provide attendees with an understanding of the 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 and for expending product approval
- The nature of shared jurisdiction over veterinary products in certain cases
- Upon completing this course on veterinary medicine regulations participants will:
- Understand how the U.S. Food and Drug Administration regulates veterinary drug products.
- 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 a NADA.
- Develop a deep understanding of what is needed to substantiate product characterization, target safety, and effectiveness.
- Analyze FDA’s rules governing chemistry, manufacturing, and controls or 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.
- Problem-solving methods to mitigate regulatory enforcement risks.
- Explain how jurisdiction is split between various Federal agencies in certain cases.
- 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 and maintaining 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
- Process owners
- Document control specialists
- Record retention specialists
- Legal Professionals
- Financial Advisors and Institutional Investors
- Consultants, Inspectors, and cGxP Experts
DAY 01(9:00 AM TO 1:00 PM PDT)
- Introduction to the Veterinary Drug Approval Process
- 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
- Discovery/Acquisition - Preliminary Patent Protection Concerns
- 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)
DAY 02(9:00 AM TO 1:00 PM PDT)
- Developing the NADA Technical Sections
- Chemistry, Manufacturing, Controls (CMC)
- The 7 Major Phases of Clinical Field Studies
- Target Animal Safety (TAS)
- Human Food Safety
- Environmental Impact
- Freedom of Information (FOI) Summary
- All Other Information (AOI)
- Overview of Generic Animal Drugs (JINAD)
- Submissions - ANADA sections
- Bioequivalence (Safety & Efficacy)
- Human Food Safety
DAY 03(9:00 AM TO 1:00 PM PDT)
- Minor Use Minor Species (MUMS)
- Marketing Exclusivity & Exclusive Marketing Rights
- Animal Drug User Fees and related waivers
- Animal Feed, OTC Drugs, Supplements, Medical Devices
- Animal health products regulated by USDA & EPA
- Non-Approval-Related Considerations
- Extra-Label Drug Use
- Noncompliance and Enforcement
- Post-approval submissions for CMC changes
- Review of the Typical Steps in Veterinary Drug Development