US FDA Collects ‘Majority’ Of PDUFA Program Fees After Payment Plea
The revenue is expected to sustain the prescription drug user fee program moving forward after reserves were tapped at the start of fiscal year 2023.
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Carryover funds are limited after the agency's collections schedule was altered by the late user fee program renewal.
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.