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EnviroTech :: Regulatory :: Regulatory: Legal

EFCG Ratifies FDA's Proposed Generic Drug User Fees Act

5:58 AM MDT | September 13, 2011 | Deepti Ramesh

The European Fine Chemicals Group (EFCG; Brussels) says its board has agreed to ratify the proposal of the U.S. Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and U.S. industry representatives, to deliver into U.S. law, a new generic drug user fees act (GDUFA). GDUFA requires the FDA to commit to significantly improve its regulatory activities for the benefit of global generic drug providers and U.S. generic drug users, in exchange for the global generics industry providing FDA with $299 million in user...

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