FDA is failing to oversee human clinical trials, report says

BMJ 2007; 335 doi: (Published 04 October 2007) Cite this as: BMJ 2007;335:691
  1. Janice Hopkins Tanne
  1. New York

Problems in the systems and management processes of the US Food and Drug Administration are hindering its ability to oversee clinical trials and to protect trial participants, says a highly critical report by the Office of the Inspector General at the Department of Health and Human Services, the FDA's parent agency.

The report, by Daniel Levinson, the inspector general, was first publicised in a front page story in the New York Times last week (, “Report assails FDA oversight of clinical trials,” 28 Sep).

The FDA oversees …

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