New GDUFA Workload Formula Will Not Include Inspections Until FY 2025 Fee-Setting
Executive Summary
Capacity planning adjustment that will help calculate generic drug user fees will not include inspections at first to allow more time for time reporting system implementation.
You may also be interested in...
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.
US FDA: Please Pay PDUFA Program Fees ASAP
Carryover funds are limited after the agency's collections schedule was altered by the late user fee program renewal.
GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.