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SPOTLIGHT: Study: Last-minute drug approvals less safe

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New England Journal of Medicine
medicine
Food and Drug Administration (FDA)
Harvard
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Safety Warnings

When FDA reviewers cram, do they perform poorly on the test? A new study concludes that yes, when drugs are approved right on deadline, they're more likely to cause safety problems later. The Harvard analysis, published in this week's New England Journal of Medicine, concludes that drugs approved in the two months leading up to the deadline are four to five times more likely to be withdrawn or require serious safety warnings. Report

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