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US FDA Changes Data Source For GDUFA II Facility Fee Setting

 
• By Derrick Gingery

Agency primarily uses application data instead of facility self-identification lists to determine FY 2018 generic drug user fees.

FDA entrance sign 2016

FDA changed the source of facility data it uses to calculate some generic drug user fees in recognition of new fee parameters, but will continue the self-identification process that had been the primary database.

In its announcement of the fiscal year 2018 generic drug user fees, the agency said it calculated the fees for...

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