Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control
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.
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Release of several different safety announcements showcases US FDA Commissioner Gottlieb's efforts to quell potential public concerns with an active communication strategy.
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
Agency's opioid response efforts have pushed advisory committee into unusual territory in recent years. But a two-day meeting to discuss potential labeling changes to recommend co-prescribing of the overdose reversal agent naloxone moved way beyond any of the conventional boundaries of committee meetings.