FDA’s new guidance explains what to do during a BIMO inspection

BY LAURA DIANGELO, MPH

Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. After a Congressional directive, the agency has now released new draft guidance on the processes and practices on BIMO inspections. The new draft guidance comes as there is a major overhaul of the Office of Regulatory Affairs (ORA) in the works, and new authorities on Remote Regulatory Assessments (RRAs) are being implemented.

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