FDA Finalizes Drug Safety Guidance for Clinical Trial Sponsors
December 16, 2025
December 16, 2025
WASHINGTON, Dec. 16 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has finalized a guidance document outlining the responsibilities of sponsors for safety reporting and assessment during investigational drug applications (INDs) and bioavailability (BA) or bioequivalence (BE) studies.
The document entitled "Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavaila . . .
The document entitled "Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavaila . . .