Beyond the Label: Ensuring That Drug Benefits Outweigh Risks in the Food and Drug Administration's Risk Evaluation and Mitigation Strategy Program

Epstein Michael S.; Shah Eric D.; Deepak Parakkal; Kushnir Vladimir M.

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Beyond the Label: Ensuring That Drug Benefits Outweigh Risks in the Food and Drug Administration's Risk Evaluation and Mitigation Strategy Program

机译：超出标签：确保药物益处超过食品和药物管理局风险评估和缓解战略计划的风险

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来源
《The American Journal of Gastroenterology》 |2019年第7期|共3页
作者
Epstein Michael S.; Shah Eric D.; Deepak Parakkal; Kushnir Vladimir M.;
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正文语种 eng
中图分类消化系及腹部疾病;
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1. Beyond the Label: Ensuring That Drug Benefits Outweigh Risks in the Food and Drug Administration's Risk Evaluation and Mitigation Strategy Program [J] . Epstein Michael S., Shah Eric D., Deepak Parakkal, The American Journal of Gastroenterology . 2019,第7期

机译：超出标签：确保药物益处超过食品和药物管理局风险评估和缓解战略计划的风险
2. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration A Review [J] . Heyward James, Olson Lily, Sharfstein Joshua M., JAMA internal medicine . 2020,第2期

机译：评估美国食品和药物管理局延期/长效阿片类药物规定风险评估和缓解战略计划审查
3. The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction [J] . Wu Jasmanda, Juhaeri Juhaeri Clinical therapeutics . 2016,第12期

机译：美国食品和药物管理局的风险评估和缓解策略（REMS）计划-现状和未来方向
4. Drugs Administration: How to Reduce Risks to Patients [C] . E. Iadanza, G. Burchietti, R. Miniati, World Congress on Medical Physics and Biomedical Engineering . 2013

机译：药物管理局：如何降低患者风险
5. Labeling of genetically modified foods: Stakeholder perceptions of the Food and Drug Administration's public consultation processes and food industry reactions to the United States voluntary and European Union mandatory policies [D] . Albert, Janice Lee 2007

机译：转基因食品的标签：利益相关者对食品药品监督管理局的公众咨询过程以及食品行业对美国自愿和欧盟强制性政策的反应的看法
6. Peer Reviewed: A Qualitative Study of Vape Shop Operators Perceptions of Risks and Benefits of E-Cigarette Use and Attitude Toward Their Potential Regulation by the US Food and Drug Administration Florida Georgia South Carolina or North Carolina 2015 [O] . Pratibha Nayak, Catherine B. Kemp, Pamela Redmon 2016

机译：同行评审：Vape商店经营者对电子烟使用的风险和收益的感知的定性研究以及美国食品药品管理局（佛罗里达州乔治亚州南卡罗来纳州或北卡罗来纳州对其潜在法规的态度）2015年
7. Mitigating the Safety Risks of Drugs With a Focus on Opioids: Are Risk Evaluation and Mitigation Strategies the Answer? [O] . Marta J. Brooks 2014

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8. Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff. [R] . 2015

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Beyond the Label: Ensuring That Drug Benefits Outweigh Risks in the Food and Drug Administration's Risk Evaluation and Mitigation Strategy Program

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