FDA's Opioid Action Plan Could Clear Califf Nomination Roadblock
This article was originally published in The Pink Sheet Daily
Policy shifts to address opioid abuse epidemic include changes to immediate-release opioid labeling, updated REMS requirements, and a new advisory committee.
You may also be interested in...
US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.
The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.