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Non-Opioid Pain Treatments Likely Not Eligible For Accelerated Approval, US FDA Says

 
• By Derrick Gingery

Other expedited pathways like fast track, priority review or breakthrough could be appropriate, according to new draft guidance.

A daily pain diary
Sponsors of non-opioid pain treatments should not rely on observational studies or EMR or claims data during development, draft guidance says. • Source: Alamy

The accelerated approval pathway appears closed for sponsors of non-opioid pain medications, although other US Food and Drug Administration expedited approval options remain available.

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