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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Detalles Bibliográficos
Autores principales: Hwang, Thomas J, Sokolov, Elisaveta, Franklin, Jessica M, Kesselheim, Aaron S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2016
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4925918/
https://www.ncbi.nlm.nih.gov/pubmed/27352914
http://dx.doi.org/10.1136/bmj.i3323

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4925918/
https://www.ncbi.nlm.nih.gov/pubmed/27352914
http://dx.doi.org/10.1136/bmj.i3323

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