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

• Main Authors: Jeffrey S. Barrett (Author), Megan Cala Pane (Author), Timothy Knab (Author), William Roddy (Author), Jack Beusmans (Author), Eric Jordie (Author), Kanwaljit Singh (Author), Jonathan Michael Davis (Author), Klaus Romero (Author), Michael Padula (Author), Bernard Thebaud (Author), Mark Turner (Author)
• Format: Book
• Published: Frontiers Media S.A., 2022-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...