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BioWorld - Wednesday, December 10, 2025

GDUFA

Home » Topics » Regulatory » GDUFA
  • Blue dollar sign on white background
    Aug. 4, 2025
    By Mari Serebrov

    Workload reductions figure into FDA’s FY2026 user fees

    While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.

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