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High-risk Therapeutic Devices Approved by the US Food and Drug Administration for Use in Children and Adolescents From 2016 to 2021

Kavya Pathak, Claire Narang, Thomas J. Hwang, Juan Espinoza, Florence T. Bourgeois

2022JAMA Pediatrics16 citationsDOIOpen Access PDF

Abstract

This cohort study examines the characteristics of high-risk therapeutic devices approved by the US Food and Drug Administration for use in children and adolescents between 2016 and 2021.

Topics & Concepts

MedicineFood and drug administrationDrugAdministration (probate law)Off-label useDrug administrationCohortCohort studyFamily medicineIntensive care medicinePediatricsEnvironmental healthPsychiatryPharmacologyInternal medicinePolitical scienceLawPharmaceutical studies and practicesEthics and Legal Issues in Pediatric HealthcareHealth Systems, Economic Evaluations, Quality of Life
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