The Big Spend-Down: US FDA Eyes $159M Reduction In Carryover User Fees
Agency will substantially reduce amount of human drug and biosimilar user fees that it carries over from year to year by the end of fiscal 2022; carryover generic drug and biosimilar fees will go toward hiring term-limited employees and building capacity, but a technical issue will keep FDA from accessing $79m in PDUFA fees.
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The minimum total will increase from eight weeks of operating expenses in FY 2023 to 10 weeks by FY 2025.
Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.
After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.