FDA Holds Meeting on Generic Drug User Fees

December 8, 2011

FDA Holds Meeting on Generic Drug User Fees

On Thursday, December 8, 2011, The Food and Drug Administration (FDA) announced a public meeting to discuss recommendations proposed for enactment of a Generic User Fee Act (GDUFA). This will give the FDA authorization to collect fees and use them in the review process for  human generic drug applications, associated Type II Active Pharmaceutical Ingredient Drug Master Files (DMFs) and for conducting associated inspections for fiscal years 2013-2017.

The meeting will be held on December 19, 2011, from 10 a.m. to 5 p.m. at the FDA White Oak Campus in Silver Spring, MD. Registration for this meeting must be received by December 12, 2011.

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