PDUFA and User Fees | Friends of Cancer Research

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PDUFA and User Fees

First signed into law in 1992, the Prescription Drug User Fees Act, or PDUFA, was passed to address growing concern among drug developers, regulators, and patients that the FDA review and approval process was taking too long due to insufficient funding. The law supplements FDA funding by requiring developers to pay user fees when they submit drugs for review. In return, the FDA sets target completion times for drug review (ten months for standard review or six months for priority review), ensuring that most New Drug Applications are addressed in a timely manner. In 1992, the FDA took 27 months on average to review a new drug. By 2012, that number had plunged to 13.3 months. PDUFA has been renewed five times and is widely considered a success by both regulators and drug developers. In 2011, user fees paid for an estimated 65% of the drug approval process. 

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