US FDA Sets FY 2021 User Fees, With Coronavirus (Somewhat) In Mind
ANDA submission rate increases, while the NDA and BLA fee drops and the biosimilar fee is unchanged.
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Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.
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.
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.