Delays in Pediatric Studies Required Under the US Pediatric Research Equity Act

This cohort study investigates delays in Pediatric Research Equity Act–required studies and issuance of noncompliance letters by the Food and Drug Administration.

Corresponding Author: Florence T. Bourgeois, MD, MPH, Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children’s Hospital, 300 Longwood Avenue, Boston, MA 02116 (florence.bourgeois@childrens.harvard.edu).

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