Hamburg, Like Industry, Wants Predictability – But In FDA Funding
This article was originally published in The Pink Sheet Daily
Executive Summary
Commissioner says the agency cannot operate effectively without predictable budgets and that sequestered user fees are needed now.
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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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