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FDA Expands Rules on the Disqualification of Clinical Investigators

In April 2012, the US Food and Drug Administration announced in the Federal Register the publication of a final rule to amend the investigational new drug application and investigational device exemption regulations regarding the clinical investigator disqualification process. Alejandra Muntañola at Thomson Reuters provides an overview of the final rule, from May 30, 2012, and how the clinical investigator is ineligible to receive any test article if he/she is disqualified by the Commissioner of Food and Drugs.