JAMA · 2022 · 10 citations · 4 references
MedicineCardiologyPediatricsAdolescent HealthPediatric CardiologyPediatric TherapeuticsCardiac Risk AssessmentCardiovascular DiseaseCardiovascular Drug SafetyPediatric Clinical TrialsPediatric Interventional CardiologyCardiovascular Risk ManagementClinical Evidence ReviewDrug Administration DatabasesDrug Approval DatabasesDrug Approval PolicyFood And Drug Administration ApprovalPediatric Drug Approval
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.
4
Off-Label Use of Medical Devices in Children
Kathy J. Jenkins, Robert H. Beekman, Michael G. Vitale et al. · PEDIATRICS · 2016 · 73 citations · Full text
Pharmacy, Pediatrics, Surgery +17