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Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected

 
• By Michael McCaughan

In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.

Car mechanic replacing timing belt at camshaft of modern engine - Image
This timing belt needs to be replaced. Could it speed up FDA's opioid guidance development?

When the US FDA announced an Nov. 15 advisory committee meeting to discuss “the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain,” it sounded like a forum to unveil a rough draft of a promised guidance on that topic.

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