Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

Puthumana Jeremy; Wallach Joshua D.; Ross Joseph S.

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Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

机译：支持FDA批准药物的临床试验证据授予突破治疗指定

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来源
《JAMA: the Journal of the American Medical Association》 |2018年第3期|共3页
作者
Puthumana Jeremy; Wallach Joshua D.; Ross Joseph S.;
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作者单位

Yale Sch Med New Haven CT USA;

Yale Univ Collaborat Res Integr &

Transparency New Haven CT USA;

Yale Sch Med Dept Internal Med New Haven CT USA;

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原文格式 PDF
正文语种 eng
中图分类医药、卫生;
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1. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation [J] . Puthumana Jeremy, Wallach Joshua D., Ross Joseph S. JAMA: the Journal of the American Medical Association . 2018,第3期

机译：支持FDA批准药物的临床试验证据授予突破治疗指定
2. Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation [J] . Kesselheim Aaron S., Woloshin Steven, Eddings Wesley, JAMA: the Journal of the American Medical Association . 2016,第14期

机译：医生对FDA批准标准的知识和“突破治疗”指定的看法
3. Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases [J] . Nagai Sumimasa, Ozawa Keiya Investigational new drugs. . 2018,第3期

机译：基于随机相3试验的药物批准用于复发恶性肿瘤：肿瘤药物的分析授予加速批准，出版物和临床试验数据库
4. Heart Failure Patients are not Receiving Evidence-Based Lifesaving Drug Therapy: Lessons from the Heart Failure Adherence and Retention Trial (HART) [C] . Calvin Jr. J.E., Powell L.H., Richardson D., International Congress on Coronary Artery Disease . 2009

机译：心力衰竭患者没有接受基于证据的救生药物治疗：来自心力衰竭依从性和保留试验的教训（HART）
5. Evidence Supporting FDA Approval and CMS National Coverage Determinations for Novel Medical Products, 2005 through 2016: A Cross-Sectional Study [D] . Roginiel, Aliya C. 2019

机译：证据支持FDA批准和CMS全国新型医疗产品的覆盖范围，2005年至2016年：横断面研究
6. Accelerated Approval and Breakthrough Therapy Designation: Oncology Drug Development on Speed? [O] . James C. Yao, Funda Meric-Bernstam, J. Jack Lee, -1

机译：加速批准和突破性疗法的指定：肿瘤药物的开发速度如何？
7. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation [O] . Jeremy Puthumana, Joshua D. Wallach, Joseph S. Ross 2018

机译：支持FDA批准药物的临床试验证据授予突破治疗指定
8. New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials [R] . 2010

机译：新药批准：FDa对某些临床试验证据的考虑

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

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