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  1. Clinical Trials and Human Subject Protection

BIMO Inspection Metrics

The slides accessed through the links below provide annual bioresearch monitoring (BIMO) inspection metrics by fiscal year (FY). The inspectional data cover all aspects of FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence, and good laboratory practices) for all Centers, as applicable. These data were provided by the individual Centers and may differ from other inspection data available on FDA’s website, as different criteria and/or methods for compiling the information may have been used. Also provided, at the first link below, is a glossary of acronyms.

This page lists the most recent reports. Metrics from previous years can be found in the FDA.gov Archive.

Annual BIMO Inspection Metrics