Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.
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DOI: 10.1182/blood-2017-04-742726
Abstract: The US Food and Drug Administration (FDA) negotiates the evidence necessary for drug approval with pharmaceutical sponsors. The resulting data package submitted in support of approval includes labeling that conveys the benefits and risks of… read more here.
Keywords: flexibility innovation; innovation fda; novel regulatory; fda novel ... See more keywords