Despite efforts to make them predictable, user fee revenues continue to prove the opposite: sponsors may have been given an increase based on an expected downturn in submissions that is not materializing.
US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike
With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.
