As industry prepares for the FDA’s draft RWE guidance in 2021, Aetion conducted a systematic review of FDA approval documents in 2019 to understand what role RWE plays in informing regulatory decisions. This eBook will guide you through when, where, and how RWE studies have supported the approvals of NDAs and BLAs, and how Aetion can serve as a partner on your next regulatory submission.
How RWE studies are used in FDA approvals
Learn how the use of RWE studies have increased over time, and why types of RWE studies are most frequently used
Analysis across therapeutic areas
Read how RWE has supported approvals across nine therapeutic areas, with deeper dives into infectious disease and oncology
How RWE studies inform prescribing
See how often RWE studies and their findings are mentioned in a drug’s package insert
Deep dives on successful and unsuccessful external control arms
Review two case studies on external controls arm submissions to the FDA — one that provided substantial evidence and one with design limitations
How to advance regulatory submissions with Aetion
Consider how Aetion Evidence Platform® can help you generate decision-ready RWE
© 2020 Aetion, Inc.