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 agency sees its personnel compensation and benefits costs decrease for the first time in at least 16 years, while the overall FTE count continues to rise.
Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.
ANDA submission rate increases, while the NDA and BLA fee drops and the biosimilar fee is unchanged.