As Pandemic Delays Reduce PDUFA Revenues, US FDA Slows Fee-Related Spending
Executive Summary
Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.
You may also be interested in...
Pandemic Effect: Sponsors Paid Far Fewer User Fees Than Expected In FY 2020
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.
PDUFA VII: FDA, Industry Agree To Set Minimum Carryover Balance Levels
The minimum total will increase from eight weeks of operating expenses in FY 2023 to 10 weeks by FY 2025.
PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.