Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections
FDA Law Blog
JUNE 10, 2024
It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.
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