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US FDA Generic Drug Applications Will Cost Less In FY 2020

Executive Summary

Increases in the number of expected ANDA submissions, facilities and entities holding approved applications means lower user fees in most GDUFA II categories starting 1 October; program fee will see the largest percentage drop, amounting to savings of $200,000 for large companies.

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GDUFA Sees First-Ever Fee Spending Decrease

Thanks in part to budget authority bump, US FDA’s generic user fee revenue spending dropped in FY 2019, and hiring problems lead to an FTE decrease. The useable GDUFA carryover balance also increased in conjunction with the user fee revenue spending reduction, from $158.7m available at the end of FY 2018 to $199.2m at the end of FY 2019.

Generic Drug User Fee Program Sees First-Ever Fee Spending Decrease, FTE Decline

Thanks in part to budget authority bump, US FDA’s generic user fee revenue spending dropped in FY 2019, and hiring problems lead to an FTE decrease. The useable GDUFA carryover balance also increased in conjunction with the user fee revenue spending reduction, from $158.7m available at the end of FY 2018 to $199.2m at the end of FY 2019.

US FDA Generic Approvals Break 900 Barrier In FY 2019

The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.

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