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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

The US Food and Drug Administration increasingly relied upon remote assessment tools, rather than on-site inspections, to evaluate clinical and analytical data from bioavailability and bioequivalence studies in the second year of the COVID-19 pandemic.

The FDA’s Bioresearch Monitoring (BIMO) program metrics for fiscal year 2021 show an 88% drop in on-site inspections of...

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