US FDA Bioresearch Monitoring Program’s Reliance On Remote Assessment Tools Grows

 
• By Sue Sutter

Remote regulatory assessments for drug bioavailability/bioequivalence studies rose 71% in FY2021 while the number of on-site inspections in this category fell by 88%; pandemic continues to drive a decline in clinical investigator inspections across FDA's BIMO program.

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The pandemic has driven an increase in FDA's use of remote assessment tools for bioresearch monitoring. • Source: Alamy

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