Articles by Jill Wechsler - Pharmaceutical Executive

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Articles by Jill Wechsler
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Washington Report: A Warning Trend

Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf?
Apr 1, 2006
By: Jill Wechsler

FDA doesn't usually write a black box warning "without some pretty good data," said Robert Temple of FDA's Office of Medical Policy. Overuse of the black box can both dilute its impact and limit access to needed treatment.

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