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BioPharmaceutical United States Risk Management

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

This article was originally published in The Pink Sheet Daily

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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