This guidance describing the processes and practices applicable to inspections of sites that are inspected under FDA’s Bioresearch Monitoring (BIMO) program. FDA’s BIMO program is a comprehensive portfolio of programs designed to assess and monitor all aspects of the conduct and reporting of FDA-regulated research facilities. This was not covered by guidance up till now.
To read the reference follow the link, click here…FDA new Guidance: Processes and Practices Applicable to Bioresearch Monitoring Inspections
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