US FDA’s Most Unusual Advisory Committee
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.
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Assistant HHS secretary for health has led policy development for several offices since his 2018 confirmation and also has industry and clinical experience.
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA expects to receive two more postmarket studies this year, but Purdue has not yet decided if it will resubmit a supplemental NDA. Consortium of 13 companies have completed six additional studies on extended-release opioids.