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BIMO Warnings Increase In Fiscal 2000, Sponsor Monitoring Problems Fewer

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health bioresearch monitoring division (BIMO) issued 23 warning letters and 137 untitled letters as of August FY 2000, a roughly 27% increase in each category compared with the full 12-month period of FY 1999.
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