Have Faster Drug Approvals Caused More Black Box Warnings, Market Withdrawals?

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Has a law designed to speed drug approvals resulted in excessive safety issues? A new study finds that after the Prescription Drug User Fee Act was passed in 1992 – in which drug makers agreed to pay fees to help fund the FDA and the agency agreed to accelerate approvals – the number of safety warnings and product withdrawals was higher than before the law was passed.

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