BIMO Processes and Practices Guidance

FDA has published a draft guidance, Processes and Practices Applicable to Bioresearch Monitoring Inspections, addressing the types of records and information to be provided, best practices for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 inspection-related conduct. The document is being issued, FDA says, to comply with a section in the Food and Drug Omnibus Reform Act of 2022 that directs the agency to issue guidance describing the processes and practices applicable to sites and facilities under the Bioresearch Monitoring Program.

The guidance includes an Introduction; Background; Processes and Practices Applicable to Bioresearch Monitoring Inspections; Best Practices for Communication Between FDA and Industry in Advance of, During, or After an Inspection; and a Resource Guide.