Notes
REMS = Risk Evaluation and Mitigation Strategy
Reference
US Food and Drug Administration. Statement on the FDA's benefit-risk framework for evaluating opioid analgesics. Internet Document : 20 Jun 2019. Available from: URL: https://www.fda.gov/news-events/press-announcements/statement-fdas-benefit-risk-framework-evaluating-opioid-analgesics
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New US draft guidance issued for benefits, risks of opioids. Reactions Weekly 1760, 6 (2019). https://doi.org/10.1007/s40278-019-64165-9
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DOI: https://doi.org/10.1007/s40278-019-64165-9