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1 in 2 of 2019 approved FDA submissions for new drugs and biologics included a real-world evidence study.


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.


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What you'll learn


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

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Analysis across therapeutic areas

Read how RWE has supported approvals across nine therapeutic areas, with deeper dives into infectious disease and oncology

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How RWE studies inform prescribing

See how often RWE studies and their findings are mentioned in a drug’s package insert

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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

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How to advance regulatory submissions with Aetion

Consider how Aetion Evidence Platform® can help you generate decision-ready RWE

The time to prepare for FDA's coming RWE guidance is now.

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Download the eBook

Learn about the role of RWE in FDA approvals.