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Legislation On CROs And IRBs Might Be One Fall-Out From Ketek Probe

Executive Summary

The House Energy and Commerce Committee is considering the need for legislation to set new parameters for organizations involved in drug development. Their concern is prompted by the failure of individuals overseeing safety study 3014 for Sanofi-Aventis' Ketek (telithromycin) to report investigator misconduct to FDA

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