Generics Approvals Will Decline, US FDA Predicts, But Supplement Work May Grow
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
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GDUFA III: US FDA Says Generic Drug Supplement Volume Could Require More Resources
Will the growing workload cause GDUFA fees to increase or prompt other changes?
Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels
Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.
FY 2019 Drug Development Drives FY 2021 User Fees Lower
Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.