eBook: The role of real-world evidence in FDA approvals


In 2019, 1 in 2 of FDA-approved NDAs and BLAs included a real-world evidence (RWE) 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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