FDA Opioid Action Plan Could Help Clear Califf Nomination Roadblock
This article was originally published in The Tan Sheet
Policy shifts to address opioid abuse epidemic include changes to immediate-release opioid labeling, updated REMS requirements, and a new advisory committee.
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Outgoing Commissioner Scott Gottlieb will leave his successor a plate full of initiatives, should he choose to continue agency engagement of them.
Trials will be mandated as part of new authority granted by SUPPORT Act and are intended to determine whether opioid efficacy decreases with long-term use.
Agency says it now has enough scientific data to act on a citizen petition noting increase in overdose deaths from concomitant prescribing of two drug classes.