Generic Drug User Fee Program Goes to Congress

The U.S. FDA says it has completed its recommendations for the proposed generic drug user fee program (GDUFA). The recommendations were transmitted by the Department of Health and Human Services to Congress on January 13. Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s drug review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame. The GDUFA is expected to create a level playing field for U.S. and overseas manufacturers...

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