WASHINGTON, Dec. 19 -- Food and Drug Administration has issued a notice called: Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability.
The notice was published in the Federal Register on Dec. 19 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Processes and Practices Applicable to Bioresearch Monitoring Inspections." This final guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to...