Landscape analysis for a neonatal disease progression model of bronchopulmonary dysplasia: Leveraging clinical trial experience and real-world data

The 21st Century Cures Act requires FDA to expand its use of real-world evidence (RWE) to support approval of previously approved drugs for new disease indications and post-marketing study requirements. To address this need in neonates, the FDA and the Critical Path Institute (C-Path) established th...

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Автори:	Jeffrey S. Barrett, Megan Cala Pane, Timothy Knab, William Roddy, Jack Beusmans, Eric Jordie, Kanwaljit Singh, Jonathan Michael Davis, Klaus Romero, Michael Padula, Bernard Thebaud, Mark Turner
Формат:	Artigo
Мова:	Inglês
Опубліковано:	Frontiers Media S.A. 2022-10-01
Серія:	Frontiers in Pharmacology
Предмети:	bronchopulmonar dysplasia neonates disease progression real world data (RWD) rare disease
Онлайн доступ:	https://www.frontiersin.org/articles/10.3389/fphar.2022.988974/full
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