Work

US Food and Drug Administration Approval of Biologic Drugs for Use in Children and Adolescents

Year: 2025

Type: article

Abstract: This cohort study assesses pediatric labeling patterns and use of US Food and Drug Administration–approved therapeutic drugs in the US from 1965 to 2024.

Source: Archives of Pediatrics and Adolescent Medicine

DOI: 10.1001/jamapediatrics.2025.5087

Authors: Ning Lyu, Sebastian Schneeweiss, Florence T. Bourgeois, Timothy J. Savage

Institutions: Harvard University, Harvard-MIT Center for Regulatory Science, Brigham and Women's Hospital

Language: English

Topic: Pharmaceutical studies and practices

Subfield: Pediatrics, Perinatology and Child Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funder: National Institutes of Health

Awards: The development of a systematic approach to harness real-world evidence for the evaluation of medication safety and effectiveness in children, New approaches to safety monitoring of novel systemic treatments for atopic dermatitis in clinical practice and underrepresented populations

OpenAlex ID: W4417129268

FWCI:

Cites: 3

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