In many ways, the pending renewal of the Prescription Drug User Fee Act should be a bright spot for FDA. Industry and the agency seem genuinely excited about the possibilities for progress in the next cycle, and FDA will get the review money no matter what happens with the automatic appropriations cuts that are looming as part of the deficit reduction deal.
PDUFA V: Can FDA Fight Off Mission Creep This Cycle?
As hearings get under way, Commissioner Hamburg says considering the jobs affected by the approval or denial of an application would be difficult and inappropriate.