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Generic Drug User Fee Aims to Level the Playing Field

6:30 PM MDT | October 17, 2011 | —Deepti Ramesh

The U.S. FDA has proposed a generic drug user fee program (GDUFA) that will create a level playing field for U.S. and overseas manufacturers of active pharmaceutical ingredients (API) and finished pharmaceuticals. GDUFA will require FDA to commit to improving significantly its regulatory activities for the benefit of generic drug providers and U.S. generic drug consumers. The global generics industry, in exchange, will provide FDA with $299 million/year in user fees over the next five years. The key benefits for drug providers will be faster and more predictable...

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