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Home » Warning Letter Cites Investigator for Reporting Failures, Lack of Consents
Warning Letter Cites Investigator for Reporting Failures, Lack of Consents
July 18, 2008
A clinical investigator studying an asthma drug failed to report the deaths of two patients and the hospitalization of a third to the institutional review board (IRB) and failed to get informed consent or assent for most of the patients he enrolled, the FDA said in a warning letter.