Opioid REMS Increases Nearly Six-Fold As US FDA Adds Immediate-Release Products
Basically every doctor prescribing any opioid is now covered by the REMS, but training remains voluntary.
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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.
Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition
In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.
Release of several different safety announcements showcases US FDA Commissioner Gottlieb's efforts to quell potential public concerns with an active communication strategy.