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FDA 2016 User Fees Hold Steady For Brands, But Are Up – And Down – For Generics

 
• By Derrick Gingery

PDUFA, BsUFA increase moderately, while GDUFA facility fees fall for the first time.

FDA user fees for innovator prescription drugs will increase just slightly for 2016, moderating from much larger spikes in recent years.

In contrast, fees for ANDAs and supplements under the new generic drug user fee program will jump nearly 30%, though...

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• By Leslie Small

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