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FDA BIMO Inspection Metrics 发布时间:2014-03-10

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.

Bioresearch Monitoring(BIMO)metrics - FY 07 - 508.zip

Bioresearch Monitoring(BIMO)metrics - FY 08 - 508.zip

Bioresearch Monitoring(BIMO)metrics - FY 09 - 508.zip

Bioresearch Monitoring(BIMO)metrics - FY 10 - 508.zip

Bioresearch Monitoring(BIMO)metrics - FY 11.zip

Bioresearch Monitoring(BIMO)metrics - FY 12.zip

Bioresearch Monitoring(BIMO)metrics - FY 13.zip

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