Innovative Trial Designs Are 'Life And Death Matter' For Pharma, Amgen Tells US FDA

Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.

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While the US Food and Drug Administrative has long emphasized the desire for more innovative trial designs, Amgen Inc. offered the agency specific advice on how it could promote their adoption.

Elliott Levy, Amgen's senior VP of global development, recommended that FDA hold informal communications with sponsors, in which there is "more asking and less talking

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