As Pandemic Delays Reduce PDUFA Revenues, US FDA Slows Fee-Related Spending
Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.
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Revenue increases are expected in FY 2021 over pre-pandemic estimates, in part because the US FDA believes sponsors may have applications that were delayed by COVID-19.
The minimum total will increase from eight weeks of operating expenses in FY 2023 to 10 weeks by FY 2025.
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.