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.

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

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.

More than mid-way through fiscal year 2024, the US Food and Drug Administration increased its net collections estimate for the...

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