FDA Oversight Of Clinical Trials: Changes Loom

Law360, New York (November 15, 2007, 12:00 AM EST) -- On Sept. 28, 2007, the Office of the Inspector General for the Department of Health and Human Services (OIG) released a report entitled "The Food and Drug Administration’s Oversight of Clinical Trials" (the Report).

The OIG issued the Report pursuant to a congressional request to review oversight of clinical trials by the U.S. Food and Drug Administration (FDA) after a series of news articles detailed vulnerabilities in enforcement and monitoring of clinical trials in humans (For example, see David Evans et al., Drug Industry Human Testing...
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