Back to: FDA Second Annual Animal Drug User Fee Educational Conference – July 2025
Lesson Content:
What makes a High-Quality Submission?
Laura Moussa
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Jordan DeSilva
Quality Assurance Specialist
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Abstract
This presentation highlights the importance of submitting high-quality information to the Center for Veterinary Medicine (CVM) for new animal drug approvals. High-quality submissions ensure efficient review processes, minimize delays, and support sound regulatory decisions. Key recommendations include organizing submissions clearly with overviews, roadmaps, and glossaries, ensuring consistency across all documents, and providing well-supported justifications for all claims. When using the eSubmitter, applicants should follow templates, answer all questions, and properly format attachments with descriptive file names and bookmarks in PDFs. Critically, copies of raw data, adhering to ALCOA principles (attributable, legible, contemporaneous, original, accurate), must be submitted to confirm study accuracy. Good documentation practices are essential for recording and maintaining reliable, reproducible data, with specific guidelines for corrections and electronic data capture (EDC) systems, which should be 21 CFR Part 11 compliant and validated. The final study report must accurately reflect the raw data and study conduct, addressing any deviations or inconsistencies. By following these best practices, sponsors can significantly improve the review timeline and increase the likelihood of a successful approval.