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The following "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain" (NIDPCE) letter was issued by the CDER Office of Medical Policy to the clinical investigator regarding his concoct of clinical studies. This and other such letters inform the recipients that FDA will commence with administrative proceedings to determine whether the investigator should be disqualified from receiving investigational products. They are available for subscribers from our RECORD RETRIEVE service for $7 plus retrieval.
Walter Gaman, M.D., Irving, TX, Oct. 23 (CDER-OMP). FDA hit the clinical investigator with six …