This three-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.
- Key goals of the seminar will include learning:
- How the U.S. Food and Drug Administration (FDA) regulates animal drug products.
- How FDA’s Center for Veterinary Medicine is organized.
- The process by which veterinary drug products are reviewed and approved.
- How to open an Investigational New Animal Drug (INAD) File.
- The FDA’s various user fees, what fee waivers are available, and how to request a fee waiver.
- The various technical sections are included in a New Animal Drug Application (NADA).
- What information is needed to substantiate product characterization, target animal safety and effectiveness.
- An overview of FDA’s rules governing chemistry, manufacturing and controls (CMC).
- The various components of an animal field study to support product approval.
- How animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.
- 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)
- 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)
- Submissions - ANADA sections
- Bioequivalence (Safety & Efficacy)
- Human Food Safety
- 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
ReviewsOverall this training was very informative, Mark was able to adapt to the virtual training well. Mark did well in presenting the information and continually verifying that everyone was following. He encouraged input and participation. The only thing I may recommend for future virtual sessions is maybe some interactive slides ("test your understanding", etc.). I enjoyed the training and I definitely left with knowledge that will be beneficial.
Regulatory and Quality Affairs Manager,
EPiQ Animal Health
The presenter for this seminar, Mark Hughes, clearly has a great depth of knowledge and experience with this subject matter. The notes are especially well done and documented and I believe the information shared in the seminar and the notes will be a great resource for us. Mark had many great examples and anecdotes from his experience that brought the material to life. Maybe at some point running through a scenario of drug development from the idea, to informational meetings with FDA/CVM, development of the protocol, pre-submission meetings with the FDA/CVM, that lays out the steps and timing for an example of the process, perhaps with and without MUMS designation.
Clinical Trial Manager,
STATKING Clinical Services
Dr Mark Hughes,
Hughes Veterinary Consulting
Dr. Mark Hughes, DVM, MS, has over 11 years of experience in veterinary drug product development and over 20 years of experience in laboratory animal medicine, development of in-vitro diagnostic tests, and research in animal reproduction. 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 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 and livestock.
Who Should AttendThis course is designed primarily for people tasked with developing new animal drugs for an animal health company or a human pharmaceutical company. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, or evaluating new technologies or applications. 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