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

Journal:

PLOS Medicine

Published:

2025-12-18

DOI:

10.1371/journal.pmed.1004651

Affiliations:

6

Authors:

7

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Institutions	Authors	Share
Harvard-MIT Center for Regulatory Science, United States of America (USA)	2.333333	0.33
Harvard Medical School (HMS), United States of America (USA)	1.333333	0.19
Boston Children's Hospital (BCH), United States of America (USA)	1.333333	0.19
London School of Economics and Political Science (LSE), United Kingdom (UK)	1.000000	0.14
Harvard Department of Population Medicine (DPM), United States of America (USA)	1.000000	0.14

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