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

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.

Corresponding Author: Florence T. Bourgeois, MD, MPH, Boston Children’s Hospital, 300 Longwood Ave, Boston, MA 02116 (florence.bourgeois@childrens.harvard.edu).

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