US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

 
• By Derrick Gingery

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.

revenue growth
The FDA raised its PDUFA revenue estimate $30m based on the pace of collections so far. • Source: Shutterstock

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