Oct. 23 at 10:51 PM
$MIST “Ongoing reviews of drug applications already under FDA review will proceed, funded by FY2024 user fees. However, communication from regulators may be slower than usual. Routine research, policy development, and most surveillance inspections are paused until appropriations resume.”
“A major limitation is that FDA cannot collect new FY 2026 user fees until Congress passes an appropriation. For example, FDA recently confirmed that the Generic Drug User Fee Amendments (GDUFA) system is deactivated until funding is restored. By law, these fees are not due until either October 1 or the first business day after appropriations are enacted—whichever is later.”
“This means no GDUFA or PDUFA annual fees are payable until the shutdown ends. However, new submissions requiring user fees (NDAs, BLAs, ANDAs, biosimilars) cannot be accepted during this period. Applications filed electronically will sit in queue until the government reopens.”
