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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The minimum total will increase from eight weeks of operating expenses in FY 2023 to 10 weeks by FY 2025.
Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.
Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.