| March
23, 2007--The
US FDA has submitted to Congress its final proposal for
reauthorizing the Prescription Drug User Fee Act (PDUFA
IV) after reviewing public comments. The current user fee
program is scheduled to expire on September 30, 2007.
Key
goals for PDUFA IV include placing PDUFA on a sound
financial footing, enhancing pre-market review, and
creating a modern post-market drug safety system that
follows products across their full lifecycle. FDA is also
proposing $6.25 million in new user fees for a voluntary
program to review direct-to-consumer television
advertisements for accuracy and balance prior to airing.
Under PDUFA IV, annual
user fees would be increased to $392.8 million, an $87.4
million increase over PDUFA III. FDA
News |
