Califf Hints At Labeling Changes For Opioids And Chronic Pain
Califf also said the agency is open to endpoints other than abstinence for new opioid use disorder treatments at the fourth annual NIH HEAL Initiative Investigator Meeting.
You may also be interested in...
CDC Advises Against Use Of Extended Release Opioids, Redefines High Dose
New clinical practice guideline recommends immediate-release opioids instead of extended-release and long-acting opioids when starting pain therapy. It specifies high dose is 50 mg morphine equivalent dose (MME) per day or higher. The 2016 guideline had set it at 90 MME/day.
Califf Urges Congressional Patience On Opioid Actions
Labeling changes for the pain products remain in active discussion, the US FDA commissioner tells the Senate Health, Education, Labor and Pensions Committee during a hearing on the monkeypox outbreak.
New Opioid Approval Standard Intended To Drive Development Into Other Therapeutics
US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.