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Home » PDUFA and Other Laws Increased FDA Authorization, Agency Still Writing Guidances As Result
PDUFA and Other Laws Increased FDA Authorization, Agency Still Writing Guidances As Result
March 11, 2009
The Prescription Drug User Fee Act (PDUFA) of 2007 reauthorizes provisions for user fees for prescription drugs and biologics and provides authority for the FDA to collect at least $510 million in fiscal 2009 from manufacturers.