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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The FDA's new capacity planning adjustment predicted many more FTEs are needed for the PDUFA and BsUFA programs in FY 2021 than the agency actually funded. • Source: File photo

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