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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Clinical Investigator Status (Biologics)

Inspections of clinical investigators who have conducted studies with investigational devices reviewed by CBER are carried out as part of the Food and Drug Administration's Bioresearch Monitoring Program. The Clinical Investigator Inspection List contains information on such inspections that were closed after 1989. The list will be updated quarterly. 

A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE letter) is issued when FDA believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448