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GDUFA: Fee Avoidance Affects Rates Again

 
• By Derrick Gingery

Industry avoided application supplement fees by using CBE submissions instead, forcing FDA to change its estimates and sending generic drug user fees higher.

A change in the type of generic drug application sponsors submit to reflect moderate manufacturing process or other changes may have significantly affected GDUFA user fees.

Much of the increase in the fiscal year 2014 generic drug user fees was attributed to a rebalancing of the burden to compensate for the loss of a fee for...

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