Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration A Review

摘要

This review evaluates the efforts of the US Food and Drug Administration (FDA) and extended-release/long-acting manufacturers to assess the effectiveness of the extended-release/long-acting opioid prescribing Risk Evaluation and Mitigation Strategies (REMS) program by evaluating manufacturer REMS assessments and FDA oversight of these assessments.