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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Will the growing workload cause GDUFA fees to increase or prompt other changes?
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.
Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.