1. Pink Sheet

Generic Drug User Fees Will Jump More Than 50% In FY 2018

 
• By Derrick Gingery

GDUFA II's fee structure shifts burden from manufacturers to sponsors though 'ANDA holder fee.'

The generic industry should prepare to pay more in support of FDA's generic drugs program when its user fee program is reauthorized.

GDUFA II will begin Oct. 1, 2017 with a revenue target of $493.6m, which is nearly 53% higher than the...

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