Opioid Prescribing Guidelines Put US FDA In Unfamiliar Territory
FDA has always described its role as stopping short of regulating the practice of medicine. When it comes to opioids, that is no longer the case.
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National Academies report identifies gaps in the existing data – including on the question of whether developing prescribing guidelines would even have an impact on the opioid epidemic.
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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