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Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program
This study uses publicly available FDA summaries to analyze the quality of evidence in pivotal studies that support cardiovascular premarket device approval under FDA priority review from 2007 to 2017.
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| Publicado no: | JAMA Intern Med |
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| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
American Medical Association
2018
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6584255/ https://ncbi.nlm.nih.gov/pubmed/30178044 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2018.3649 |
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