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...

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Dades bibliogràfiques
Publicat a:BMJ
Autors principals: Hwang, Thomas J, Sokolov, Elisaveta, Franklin, Jessica M, Kesselheim, Aaron S
Format: Artigo
Idioma:Inglês
Publicat: BMJ Publishing Group Ltd. 2016
Matèries:
Research
Accés en línia: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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