FDA GUIDANCE · FINALJune 4, 2025

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

What this record is not

Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Premarket, Environmental Safety, Human Food Safety, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Target Animal – Effectiveness, Target Animal – Safety

Issue date

June 4, 2025

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