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...
Generic Drug User Fees Will Jump More Than 50% In FY 2018
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GDUFA II's fee structure shifts burden from manufacturers to sponsors though 'ANDA holder fee.'
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