Upcoming Login Downtime

We're updating the Biocentury.com platform login experience to make access more secure and reliable. As part of this update, logins will be temporarily unavailable on Sunday, March 16, from 4:00AM to 4:00PM GMT. We recognize the inconvenience and appreciate your understanding. Please check back after the maintenance period.

For updates, questions, or issues, please call us at +1 650-552-4224 or email us at support@biocentury.com.

BioCentury
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...

Get Unlimited Access
Continue reading with a free trial.
Or Purchase This Article