Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities

Author:

Massaro An N.ORCID,Boyer Beth,Gill Mira,Kim Dure,Laughon Matthew,Walsh Michele,Lemmon Monica E.,Pilon Betsy,Baer Gerri,Barrington Keith,Bianchi Diana W.,Cross JaNeen,Darcy-Mahoney Ashley,Discenza Deb,Fuentes Daniel,Green Dionna,Hamre Gerrit,Hill Kevin,Jensen Erik,Knoble Naomi,Lapointe Nancy Allen,Lestini Melissa,Marston Hilary,McCune Susan,Offringa Martin,Pedroza Claudia,Schmidt Barbara,Seo Suna,Singh Kanwaljit,Soul Janet S.,Taylor Genny,Watterberg Kristi,Zimmerman Kanecia

Funder

U.S. Department of Health and Human Services

US FDA

Publisher

Elsevier BV

Reference17 articles.

1. US Food and drug administration Modernization Act,1997

2. Best Pharmaceuticals for children Act,2002

3. Pediatric research Equity Act,2003

4. US Food and drug administration safety and innovation Act,2012

5. Drug labeling and exposure in neonates;Laughon;JAMA Pediatr,2014

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