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Perspective
Volume 353:969-972 September 8, 2005 Number 10
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FDA Standards — Good Enough for Government Work?
Jerry Avorn, M.D.

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The cliché "good enough for government work" implies that lower standards are acceptable for a job sponsored by a public agency. But in biomedical research, the opposite is usually true. The National Institutes of Health has always had tough standards; its newly constrained funding is leading to an even more stringent review process, so that near-perfect evaluation scores are now required to win support. Similarly stringent criteria prevail at the National Science Foundation. Yet there is one area of biomedicine in which the government allows — even defends — a minimal standard that would be unacceptable anywhere else in research. . . . [Full Text of this Article]


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Dr. Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, Boston.

An interview with Dr. Avorn can be heard at www.nejm.org.


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