GDUFA And BsUFA Fees Set To Leap

US FDA Corrects Errors, Limits PDUFA Application Fee Increase

 
• By Derrick Gingery

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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The FDA did not account for fee refunds and waivers in its FY 2023 and FY 2024 FAE calculations • Source: Shutterstock

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