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FDA's Opioid REMS Review Puts Brakes On Mandatory Education Push

 
• By Sue Sutter

Requiring training and certification for extended-release opioids would involve at least 320,000 prescribers and impact 21 million outpatient prescriptions, reviewers note in a briefing memo that is more skeptical of the mandatory approach than FDA's leadership has been.

Although FDA Commissioner Robert Califf has expressed support for mandatory education of opioid prescribers, an agency review of the current Risk Evaluation and Mitigation Strategy for extended-release/long-acting (ER/LA) opioids is less sanguine about such an approach.

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