US FDA Faced With Suite Of Opinions Defining 'Clinically Meaningful' Opioid-Sparing Claims
Advisory committee agreed that statistically significant reduction in average opioid use and decrease in absolute amount were insufficient components on their own; a decrease in duration of use and a decrease in the amount of patients who don't need opioids received some support.
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FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices.
The advisory committee will discuss a broad range of questions on a facet of FDA's opioid strategy that has received less attention than the others.
"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."