Processes and Practices Applicable to Bioresearch Monitoring Inspections | FDA

Docket Number: FDA-2023-D-5021 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Devices and Radiological Health Human Foods Program Center for Tobacco Products Center for Veterinary Medicine 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 inspections of sites and facilities inspected under FDA’s Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The guidance covers the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct. Submit Comments Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2023-D-5021.