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What is PDUFA?

April 26, 2017pdufa

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What is PDUFA?

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The Prescription Drug User Fee Act (PDUFA), enacted in 1992 and renewed in 1997 (PDUFA II) and 2002 (PDUFA III) authorizes FDA to collect fees from companies that produce certain human drug and biological products. PDUFA established three types of user fees – application fees, establishment fees, and product fees. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.