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

The 21(st) 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...

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Detalles Bibliográficos
Autores principales: Barrett, Jeffrey S., Cala Pane, Megan, Knab, Timothy, Roddy, William, Beusmans, Jack, Jordie, Eric, Singh, Kanwaljit, Davis, Jonathan Michael, Romero, Klaus, Padula, Michael, Thebaud, Bernard, Turner, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Pharmacology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9597633/
https://www.ncbi.nlm.nih.gov/pubmed/36313352
http://dx.doi.org/10.3389/fphar.2022.988974

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