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.

Gorde:
Xehetasun bibliografikoak
Argitaratua izan da:JAMA Intern Med
Egile Nagusiak: Jones, L. Camille, Dhruva, Sanket S., Redberg, Rita F.
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: American Medical Association 2018
Gaiak:
Research Letter
Sarrera elektronikoa: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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