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What Makes a "Breakthrough" Therapy? Woodcock Says More Details are Coming


9/19/2013 7:43:51 AM

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It’s been more than a year since the start of the Food & Drug Administration’s “Breakthrough” therapy designation, and there are still a lot of questions from drug sponsors about the specifics of the program. At every public discussion on FDA’s new Breakthrough therapy designation – and there have been quite a few recently – industry executives have peppered agency officials with questions about which products qualify as a “Breakthrough,” often including specifics about their particular development programs.

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Read at Elsevier

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