Did PDUFA Sacrifice Safety for Speed?

August 5, 2014 6:31 PM

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It's true that 1992 was a watershed year for the FDA and pharmaceutical manufacturers. That was the year Congress passed the Prescription Drug User Fee Act, or PDUFA, under which the agency began collecting application fees from drugmakers seeking new drug approvals.

In turn, the FDA was to use the revenue to hire more scientists to review applications, cutting what had become an embarrassingly long average time between application filings and final decisions.

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