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Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis

BACKGROUND: The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical devices. OBJECTIVES: The purpose of our stud...

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Detalles Bibliográficos
Autores principales:	Moon, John T., Konstantinidis, Menelaos, Song, Nevon, Nezami, Nariman, Majdalany, Bill S., Herr, Allen, Siskin, Gary
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Cambridge University Press 2023
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10052441/ https://www.ncbi.nlm.nih.gov/pubmed/37008598 http://dx.doi.org/10.1017/cts.2023.10

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