CVM GFI #287 – Raw Data for Safety and Effectiveness Studies

Issue Date: June 4, 2025
Issued by: Center for Veterinary Medicine
Topic(s): Premarket, Environmental Safety, Human Food Safety, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Target Animal – Effectiveness, Target Animal – Safety
Status: Final

CVM GFI #287 – Raw Data for Safety and Effectiveness Studies

This guidance provides recommendations to sponsors on submission of raw data. In addition, this guidance discusses how CVM uses the raw data during review of new animal drug applications and how the raw data allows CVM to have confidence in the information used to make regulatory decisions.

Download the Guidance Document

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