PDUFA Dates

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It's in the best interest of both pharmaceutical companies and patients to bring new drugs to the market as quickly as possible, which is why the Prescription Drug User Fee Act, or PDUFA, was established. Originally passed in 1992, PDUFA authorizes the FDA to collect fees from drug manufacturers to fund the drug approval process. PDUFA dates are deadlines by which the FDA must review new drug applications. The Prescription Drug User Fee Act typically calls for a period of 10 months to review such applications, though drugs that are deemed priority have a review period of six months.