Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections
FDA Law Blog
JUNE 10, 2024
This draft guidance, titled “ Processes and Practices Applicable to Bioresearch Monitoring Inspections ,” was prompted by a congressional directive under the Food and Drug Omnibus Reform Act and is intended to provide recommendations that are not otherwise specified in existing publicly available guides and manuals for such inspections (see pgs.
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