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Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program

机译：评估食品和药物管理局优先审查计划批准的高风险心血管设备临床试验证据

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L. Camille Jones; Sanket S. Dhruva; Rita F. Redberg;
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1. Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program [J] . Jones L. Camille, Dhruva Sanket S., Redberg Rita F. JAMA internal medicine . 2018,第10期

机译：评估食品和药物管理局批准的高危心血管设备临床试验证据优先审查计划
2. Assessment of ClinicalTrial Evidencefor High Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program (vol 178, pg 1418, 2018) [J] . Jones L. C., Dhruva S. S., Redberg R. F. JAMA internal medicine . 2019,第5期

机译：评估食品和药物管理局优先审查计划（Vol 178，PG 1418,2018）批准的高风险心血管设备临床试验证据
3. Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices [J] . Ong Caroline, Ly Vy K., Redberg Rita F. JAMA internal medicine . 2020,第5期

机译：优先权与标准美国食品和药物管理局对高风险医疗器械的预售审批审查的比较
4. CARDIOVASCULAR MEDICAL DEVICES: REGULATORY SCIENCE RESEARCH OVERVIEW IN THE OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) AT THE FOOD AND DRUG ADMINISTRATION (FDA) [C] . Kenneth Aycock, Ksenia Blinova, Maura Casciola, Design of Medical Devices Conference . 2021

机译：心血管医疗器械：监管科学研究概述在食品和药物管理局（FDA）的科学与工程实验室（OSEL）办公室
5. Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving US Food and Drug Administration Premarket Approval in 2010 and 2011. [D] . Rathi, Vinay Kumar. 2016

机译：在2010年和2011年获得美国食品药品监督管理局上市前批准的高风险治疗性医疗器械整个产品生命周期中进行的临床研究。
6. Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011–2017: Lessons Learned for Anticancer Drug Development [O] . Stephanie Faucette, Santosh Wagh, Ashit Trivedi, 2018

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7. TCT-358 Food And Drug Administration Approved Cardiovascular Medical Devices: A Ten Year Review Of The Participation Of Women And Ethnic Subgroups [O] . Gallauresi Beverly, Dave Dipali 2012

机译：TCT-358食品药品监督管理局批准的心血管医疗器械：妇女和族裔参与的十年回顾
8. FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff [R] . 2014

机译：FDa关于研究设备豁免的决定临床调查：赞助商指南，机构审查委员会和食品药品管理局工作人员

Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program

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