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

Executive Summary

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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US FDA Aims To Simplify Terminology For Remote Assessments

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