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Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study

Objective To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union. Design Cohort study. Setting Novel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité...

詳細記述

保存先:
書誌詳細
出版年:BMJ
主要な著者: Hwang, Thomas J, Sokolov, Elisaveta, Franklin, Jessica M, Kesselheim, Aaron S
フォーマット: Artigo
言語:Inglês
出版事項: BMJ Publishing Group Ltd. 2016
主題:
オンライン・アクセス:https://ncbi.nlm.nih.gov/pmc/articles/PMC4925918/
https://ncbi.nlm.nih.gov/pubmed/27352914
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmj.i3323
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