PDUFA Needs More Than 300 Additional FTEs, New US FDA Capacity Planning Formula Says
But the agency chose to fund only a small fraction of them, in part because of its hiring ability, and in part because all those employees would have cost an additional $98.7m in user fee revenue.
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Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.
Other subgroups negotiating specific issues for the user fee reauthorization have indicated that agreements are close.
After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.