US FDA: Please Pay PDUFA Program Fees ASAP
Carryover funds are limited after agency's collections schedule was altered by late user fee program renewal in Congress.
You may also be interested in...
Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.
Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.
Nearly 70% of the FDA workforce would be retained, most from carryover user fee dollars, but potential morale problems loom if government funding runs out again.