REMS Assessment Challenges Shine Through In Opioids Review

Longitudinal studies and possibly a randomized, controlled trial are needed, FDA's advisory committee says; panelists were underwhelmed by product sponsors' survey, surveillance and drug utilization data.

Eight years after FDA's authority to require Risk Evaluation and Mitigation Strategies took effect, the agency and industry are still grappling with how best to assess the programs' effectiveness.

So too are FDA's external advisors, who during a two-day review of the REMS for extended-release/long-acting opioids were underwhelmed by...

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