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CDRH Focuses Bioresearch Inspections On Sponsor Monitoring In FY 99

This article was originally published in The Gray Sheet

Executive Summary

Inadequate monitoring of clinical trial sites was found in over 50% of inspections of device study sponsors in fiscal year 1999, Charma Konnor, director of the Division of Bioresearch Monitoring within the Center for Devices and Radiological Health told attendees at a Dec. 16 session of the Food & Drug Law Educational Conference in Washington, D.C.

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