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.
How does FDA use RWE studies to inform approvals?
What impact does RWE have across therapeutic areas?
How do RWE studies inform prescribing?
What factors influenced the success of external control arms?
How can Aetion help you generate decision-grade RWE?