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在“Elsevier电子期刊”中，命中：5,846条，耗时：小于0.01 秒

1.Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015

作者：Comeron W. Ghobadi ; MD^a ; ^{comeron.ghobadi@uchospitals.edu} ; Emily L. Hayman ; MD^b ; Joshua H. Finkle ; MD^a ; Jessica R. Walter ; MD^c ; Shuai Xu ; MD ; MSc(Lond)^d

关键词：Medical device innovation ; FDA ; patient safety ; health policy ; medical device regulation ; innovation ; 21st Century Cures Act ; National Evaluation System for Health Technology

刊名：Journal of the American College of Radiology

出版年：2017

2.Spinal devices in the United States—investigational device exemption trials and premarket approval of class III devices

关键词：Class III device ; Investigation device exemption ; Noninferiority trial ; Premarket approval ; Randomized clinical trial ; Spinal device

刊名：The Spine Journal

出版年：2017

3.Post-Approval U.S. Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

作者：Vivek Y. Reddy ; MD^a ; ^{vivek.reddy@mountsinai.org} ; Douglas N. Gibson ; MD^b ; Saibal Kar ; MD^c ; William O&rsquo ; Neill ; MD^d ; Shephal K. Doshi ; MD^e ; Rodney P. Horton ; MD^f ; Maurice Buchbinder ; MD^g ; Nicole T. Gordon ; BSEE^h ; David R. Holmes ; MDⁱ

关键词：atrial fibrillation ; complications ; left atrial appendage closure ; stroke ; Watchman

刊名：Journal of the American College of Cardiology

出版年：2017

4.Review of Nonformulary Medication Approvals in an Academic Medical Center

作者：Qoua L. Her ; PharmD ; MS ; MSc ; ^{Qoua_Her@harvardpilgrim.org}Author Vitae ; Mary G. Amato ; PharmD ; MPH ; BCPSAuthor Vitae ; Diane L. Seger ; RPhAuthor Vitae ; James F. Gilmore ; PharmD ; BCPSAuthor Vitae ; John Fanikos ; RPh ; MBAAuthor Vitae ; Julie M. Fiskio ; BSAuthor Vitae ; David W. Bates ; MD ; MScAuthor Vitae

刊名：The Joint Commission Journal on Quality and Patient Safety

出版年：2017

5.Midyear Commentary on Trends in Drug Delivery and Clinical Translational Medicine: Growth in Biosimilar (Complex Injectable Drug Formulation) Products Within Evolving Collaborative Regulatory Interagency (FDA, FTC, and DOJ) Practices and Enforcement

作者：Rodney J.Y. Ho

关键词：drug delivery systems ; follow-on biologics ; biocompatibility ; bioequivalence ; monoclonal antibody ; regulatory approval and enforcement ; biosimilar ; BLA ; BPCI

刊名：Journal of Pharmaceutical Sciences

出版年：2017

6.Off-label and unlicensed drug use: Results from a pilot study in a paediatric intensive care unit

作者：Isabel Garcí ; a-Ló ; pez^a ; ^{iglopez@salud.madrid.org} ; Javier Ezequiel Fuentes-Rí ; os^b ; Silvia Manrique-Rodrí ; guez^b ; Cecilia M. Ferná ; ndez-Llamazares^b

关键词：Paediatric intensive care units ; Drug utilization ; Drug approval ; Off-label use ; Unlabeled indication ; Off-label prescriptions ; Paediatrics

刊名：Anales de Pediatría (English Edition)

出版年：2017

7.Forgotten antibiotics: a follow-up inventory study in Europe, the USA, Canada and Australia

作者：Cé ; line Pulcini^a ; ^{celine.pulcini@univ-lorraine.fr} ; Simone Mohrs^b ; Bojana Beovic^c ; Inge Gyssens^d ; ^e ; Ursula Theuretzbacher^f ; Otto Cars^b ; on behalf of the ESCMID Study Group for Antibiotic Policies (ESGAP) ; ReAct Working Group on Old Antibiotics¹ ; Bojana Beovic ; Golubinka Bosevska ; Marcel Bruch ; Karen Bush ; Otto Cars ; Lidija Cizmovic ; Nick Daneman ; Bé ; atrice Demoré ; Aleksander Deptuła ; Uga Dumpis ; Aoife Fleming ; Niels Frimodt-Mǿller ; Helen Giamarellou ; Ljiljana Gojkovic-Bukarica ; Thorolfur Gudnason ; Inge Gyssens ; Hakan Hanberger ; Stephan Harbarth ; Arjan Harxhi ; Todor Kantardjiev ; Doubravka Kostalova ; Vladimir Krcmery ; Katrin Kurvits ; Endre Ludwig ; Outi Lyytikä ; inen ; Alasdair MacGowan ; Simone Mohrs ; Sí ; le O'Connor ; Leonardo Pagani ; George L. Petrikkos ; Gabriel Adrian Popescu ; Cé ; line Pulcini ; Lul Raka ; José ; Ramó ; n Pañ ; o Pardo ; Liliana Cristina Ramos Dias ; Hege Salvesen-Blix ; Gunnar Skov Simonsen ; Evelina Tacconelli ; Ursula Theuretzbacher ; John Turnidge ; Rolanda Valintėlienė ; Vera Vlahović-Palčevski ; Peter Zarb ; Helena Zemlickova

关键词：Bacterial resistance ; Drug approval ; Drug marketing ; Antibiotic stewardship

刊名：International Journal of Antimicrobial Agents

出版年：2017

8.Neuroprosthetics and the science of patient input

作者：Heather L. Benz^a ; ^{heather.benz@fda.hhs.gov} ; Eugene F. Civillico^b ; ^{eugene.civillico@fda.hhs.gov}

关键词：ACMC ; Assessment of Capacity for Myoelectric Control ; BCI ; Brain-Computer Interface ; CDER ; Center for Drug Evaluation and Research ; CDRH ; Center for Devices and Radiological Health ; DARPA ; Defense Advanced Research Projects Agency ; EMG ; electromyogram ; HDE ; Humanitarian Device Exemption ; IDE ; Investigational Device Exemption ; MDIC ; Medical Device Innovation Consortium ; NHP ; Nottingham Health Profile ; PMA ; Premarket Approval ; PRO ; patient-reported outcome ; PSFS ; Patient-Specific Functional Scale

刊名：Experimental Neurology

出版年：2017

9.Innovation under regulatory uncertainty: Evidence from medical technology

作者：Ariel Dora Stern ^{astern@hbs.edu}

关键词：Regulation ; Innovation ; FDA ; Medical devices

刊名：Journal of Public Economics

出版年：2017

10.Immunotherapy for the Treatment of Urothelial Carcinoma

作者：Nicholas M. Donin ; Andrew T. Lenis ; Stuart Holden ; Alexandra Drakaki ; Allan Pantuck ; Arie Belldegrun ; Karim Chamie ; ^{kchamie@mednet.ucla.edu}

关键词：BCG vaccine ; cancer vaccines ; cell cycle checkpoints ; immunotherapy ; urologic neoplasms

刊名：The Journal of Urology

出版年：2017

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