CDRH Focuses Bioresearch Inspections On Sponsor Monitoring In FY 99
This article was originally published in The Gray Sheet
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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