1. Pink Sheet

Growing Pains For US FDA Oversight Of Opioids: Starting Over On Assessment Of REMS

 
• By Michael McCaughan

Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.

Restart

The US Food & Drug Administration is likely to revise the plans for assessing the opioid class-wide risk management program to ask for a number of different studies to test aspects of the continuing medical education program incorporated into the Risk Evaluation & Mitigation Strategy program.

Based on feedback during a 11 December workshop on the opioid REMS assessment process, FDA may need to “to...

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