Opioid Policy At US FDA: Over-Promising Or Overreacting?
As President Trump signs SUPPORT Act, former FDA chief counsels offer dueling interpretations of agency's impact in combating opioid crisis.
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Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the
Drug manufacturer reimbursement support services also are garnering a growing amount of enforcement attention, and misleading promotion - whether on- or off-label - remains on the radar of government investigators.
US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids.