Back to: FDA First Annual Animal Drug User Fee Educational Conference – July 2024
Lesson Content:
Target Animal Safety Technical Section Overview, Target Animal Effectiveness
Prajwal Regmi
Veterinary Medical Officer
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Clinical Pharmacology
Mark Heit
Clinical Pharmacology Team
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
TAS & Effectiveness Best Practices
Cheryl Johnson
Veterinary Medical Officer
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
TAS & Effectiveness Hot Topics
Andrew Fidler
Veterinary Medical Officer
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Chemistry, Manufacturing and Controls Technical Section Overview
Peter Bryk
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Abstract
This webinar provides an in-depth exploration of key technical sections essential for new animal drug approvals, including target animal safety, effectiveness, and chemistry, manufacturing, and controls (CMC). It emphasizes the critical importance of establishing a margin of safety for target animals and demonstrating the drug’s intended effect through robust studies. The discussion highlights the role of pharmacology in understanding drug behavior, optimizing formulations, and extending study results. Best practices for submitting high-quality information are detailed, stressing clear communication with the Center for Veterinary Medicine (CVM), comprehensive protocol design, and adherence to good documentation practices. The presentation also covers modern approaches like adaptive study designs and the acceptable use of foreign data or published literature. It delves into the nuances of CMC, focusing on ensuring product quality, consistency across batches, and maintaining good manufacturing practices (cGMP) throughout a drug’s lifecycle. Common submission gaps are addressed, providing guidance on avoiding delays and ensuring successful review outcomes, ultimately aiming to facilitate the approval of safe and effective animal drugs.