Back to: FDA First Annual Animal Drug User Fee Educational Conference – July 2024
Lesson Content:
Opening Remarks
Walt Ellenberg, Moderator
Special Advisor
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Welcome
Robert M. Califf
United States Commissioner of Food and Drugs
Welcome
Matt Lucia
Director
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Ground Rules/Overview
Walt Ellenberg
Special Advisor
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
INAD to NADA
Elizabeth Hasbrouck
Project Manager
Office of New Animal Product Evaluation
Center for Veterinary Medicine, FDA
Abstract
This webinar, the first annual Animal Drug User Fee Educational Conference, provides a foundational understanding of the new animal drug approval process. The US Food and Drug Administration (FDA) and its Center for Veterinary Medicine (CVM) aim to strengthen regulatory programs and enhance communication with the animal drug industry. CVM’s Office of New Animal Drug Evaluation (ONADE) leads the pre-market review of new animal drugs, ensuring they are safe and effective for animals and that food derived from treated animals is safe for human consumption, reflecting the essential connection between animal and human health. The Animal Drug User Fee Act (ADUFA) provides vital resources for this systematic review of a drug’s safety, effectiveness, and quality. The approval pathway involves establishing an Investigational New Animal Drug (INAD) file, early and consistent communication with CVM project managers, submitting protocols and data for various technical sections, and ultimately a New Animal Drug Application (NADA). The presentation also outlines incentives such as Minor Use/Minor Species (MUMS) designation, Conditional Approval, and Priority Zoonotic Animal Drug (PZAD) designation, alongside details on user fees, available waivers, and the electronic submission process via eSubmitter. Emphasizing the importance of high-quality submissions, the conference highlights how collaborative efforts improve review timelines and facilitate the approval of safe and effective animal drugs.