Aetion Publishes 2021 eBook Showcasing RWE in Successful FDA Submissions

Aetion has published an eBook following an investigation into when and how real world evidence (RWE) successfully supports submissions to the Food and Drug Administration (FDA). The eBook explores RWE across therapeutic areas and identifies factors that influence external control arms.

“Aetion conducted a systematic review of FDA approval documents to understand the role RWE plays in providing evidence of safety and/or effectiveness in regulatory decisions. This year’s eBook will guide you through when, where, and how RWE supported approvals in 2020.” Download the eBook here.

(Source: Aetion, 10/21)