FDA Hit for Poor Clinical Trial Oversight

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Just when Food and Drug Administration officials thought they could relax a little after months debating legislation to ensure safe drug use, federal investigators leveled charges that agency oversight of clinical research is weak, disorganized, and thus unable to ensure the safety of clinical research participants. This criticism came from the Office of the Inspector General (OIG) in the Department of Health and Human Services (HHS), which has called repeatedly over the past decade for stronger efforts to monitor clinical research and to take action against rule violators. Sen. Charles Grassley (R-Iowa), who requested the OIG investigation as part of his campaign to uncover FDA malfeasance, promised to keep a close watch over how FDA implements the OIG recommendations.

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Author(s): 
Jill Wechsler
Journal: 
Applied Clinical Trials, Nov 1, 2007
Copyright: 
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