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Opioid REMS: FDA Sees No Clear Verdict On Risk Management Program's Impact

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency raises generalizability concerns with prescriber and patient surveys conducted to assess impact of REMS for extended-release/long-acting opioids; surveillance data provide little evidence the REMS has resulted in changes in safety outcomes but also do not demonstrate the program has been ineffective.

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