Susmitha Wunnava, Timothy A. Miller, Claire Narang, Meena Nathan, Florence T. Bourgeois
Abstract
This study uses data from US Food and Drug Administration (FDA) databases to quantify approval of high-risk cardiovascular devices for use in pediatric populations and assess the clinical evidence supporting the approvals.
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This study uses data from US Food and Drug Administration (FDA) databases to quantify approval of high-risk cardiovascular devices for use in pediatric populations and assess the clinical evidence supporting the approvals.
Key concepts: Medicine, Food and drug administration, Drug approval, Drug, Drug labeling, Administration (probate law), Drug administration, Intensive care medicine