Clinical Research Disqualifications

Disqualification Notices

A NIDPOE letter informs the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to the Food and Drug Administration's regulations. Generally, FDA issues a NIDPOE letter when it 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.

Disqualification Hearings

Presiding Officer Reports and Commissioner's Decisions in Clinical Investigator Disqualifications Proceedings. If the presiding officer does not agree that the Investigator should be disqualified, he will make that recommendation to the Commissioner who will make the final decision. The last attempted disqualification was Dr. Singleton during 2004. He was not disqualified. Others have been issued NIDPOE letters and their disqualification(s) are pending (Wholey, Hagaman, Campbell, Hendrick, Rossner) or have been settled by voluntary consent decree (Farber, McLeod, Phillips and Marcus).