ARTICLE | Regulation

What was fixed in PDUFA III

May 28, 2002 7:00 AM UTC

The third round of the Prescription Drug User Fee Act, which passed Congress last week with near unanimous votes, retains all of the deadlines and commitments from PDUFA II, while giving FDA additional money to conduct reviews more rapidly and consistently, according to Genzyme Chairman and CEO Henri Termeer.

Under PDUFA III, FDA's user fee revenues from biotech and pharmaceutical companies could reach $260 million in fiscal 2007, up from $162 million in fiscal 2002...