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Monheit Law : Blog Home : April 2005 : 2005-04-11
The Food and Drug Administration's dramatic decision to rein in the use of a wide array of popular painkillers reflects a broader shift at the powerful agency, which has been battered by six months of controversy over its handling of drug safety issues, say observers in academia and industry and public health advocates. Certain drug risks that used to be acceptable to the agency have become unacceptable, and benefits that usually guaranteed approval of a new drug are no longer a sure bet - but whether that is good or bad depends on an observer's viewpoint.
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