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Pediatric studies and labeling additions required by the U.S. FDA for novel drugs approved from 2011 to 2023: A retrospective cohort study.

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Title: Pediatric studies and labeling additions required by the U.S. FDA for novel drugs approved from 2011 to 2023: A retrospective cohort study.
Authors: McGonigle, Rylee1,2 (AUTHOR), Naci, Huseyin3 (AUTHOR), Siebert, Maximilian1 (AUTHOR), Ouvina, Michelle1,2 (AUTHOR), Gutiérrez-Sacristán, Alba4 (AUTHOR), Wagner, Anita K.5 (AUTHOR), Bourgeois, Florence T.1,2,6 (AUTHOR) florence.bourgeois@childrens.harvard.edu
Source: PLoS Medicine. 12/17/2025, Vol. 22 Issue 12, p1-15. 15p.
Database: Academic Search Ultimate
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ISSN:15491277
DOI:10.1371/journal.pmed.1004651