FDA Finalizes Guidelines for Bioresearch Monitoring Inspections
December 20, 2025
December 20, 2025
WASHINGTON, Dec. 20 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued a final guidance document outlining the procedures for bioresearch monitoring inspections.
This document fulfills requirements set by the Food and Drug Omnibus Reform Act of 2022, which mandated that FDA provide a clear framework for how it conducts oversight of research sites and facilities.
The guidance applies to the Bioresearch Monitoring program, whic . . .
This document fulfills requirements set by the Food and Drug Omnibus Reform Act of 2022, which mandated that FDA provide a clear framework for how it conducts oversight of research sites and facilities.
The guidance applies to the Bioresearch Monitoring program, whic . . .