1. Pink Sheet

US FDA Generic Drug Applications Will Cost Less In FY 2020

 
• By Sue Sutter

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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Come October, generic drug sponsors will pay the US FDA less for each application. • Source: Shutterstock

The US Food and Drug Administration filing fee for an abbreviated new drug application will drop slightly in fiscal year 2020, thanks to a higher number of generic drug applications expected to be submitted in the coming year.

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