Prescription drug application user fees will increase again in fiscal year 2025, although not as much as the previous year, while similar charges for generics and biosimilars will spike.
US FDA Corrects Errors, Limits PDUFA Application Fee Increase
The agency used a 10-year average with updated figures to calculate the FY 2025 PDUFA application fee and limit the impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket.
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