FDA publishes Draft Guidance for Industry: Processes and Practices Applicable to BIMO Inspections
06/18/2024
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On June 5th 2024, the US Food and Drug Administration (FDA) released a draft guidance for industry on the processes and practices that apply during an FDA Bioresearch Monitoring (BIMO) inspection in compliance with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA).