Prescription drug application user fees, which are charged for Rx-to-OTC switch applications, will increase again in fiscal year 2025, although not as much as the previous year, while similar charges for generics and biosimilars will spike.
Key Takeaways
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PDUFA, GDUFA and BsUFA application fees are set to increase again in FY 2025.
PDUFA fees for applications requiring clinical data will jump 6.5% to $4.31m in the upcoming fiscal year compared to FY2024.
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