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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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.
Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.