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The Food and Drug Administration Safety and Innovation Act of 2012: Assessing the Impact on Industry (Prescription Drug, Generic, and Biosimilar User Fees)
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The legislation’s drug provisions will have a significant impact on both innovators and generics. Major provisions affecting drug developers include enhancements to the “fast-track” and “accelerated approval” pathways, an extension of the timeline for generic drug exclusivity forfeitures, establishment of a timeline for FDA to respond to petitions requesting determinations on whether a drug was withdrawn for safety or effectiveness reasons, and a new shortened timeline for FDA to respond to petitions requesting a stay of action on pending generic applications.
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