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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Detalles Bibliográficos
Publicado en:JAMA Intern Med
Main Authors: Jones, L. Camille, Dhruva, Sanket S., Redberg, Rita F.
Formato: Artigo
Idioma:Inglês
Publicado: American Medical Association 2018
Assuntos:
Research Letter
Acceso en liña: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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