Pediatric studies and labeling additions required by the U.S. FDA for novel drugs approved from 2011 to 2023: A retrospective cohort study. - McGonigle, Rylee; Naci, Huseyin; Siebert, Maximilian; Ouvina, Michelle; Gutiérrez-Sacristán, Alba; Wagner, Anita K.; Bourgeois, Florence T. (PLoS Medicine, 2025)