The latest version of the Prescription Drug Use Fee Act (PDUFA), which mandates user fees from drug companies in exchange for advice and a more efficient review process by the US Food and Drug Administration, is due before Congress in 2007 for reapproval. Discussions will soon be underway between the FDA and key stakeholders, such as industry and patient groups, to shape the act?s fourth iteration. While credited with speeding up the drug approval process ? the FDA has whittled postclinical approval times to less than two years as industry has doubled its face-time with the FDA ? clinical development times are rising again to pre-PDUFA levels. This, the possibility of increased fees, and the question of the FDA?s ability to sustain more advisory meetings with companies, have focused attention on the bang PDUFA offers for the buck.
Since its inception in 1992, median approval times for the review of ...
