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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...
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| Veröffentlicht in: | BMJ |
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| Hauptverfasser: | , , , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
BMJ Publishing Group Ltd.
2016
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| Schlagworte: | |
| Online Zugang: | 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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