Aetion

78% of FDA approvals / NDAs and BLAs in 2020 included an RWE study.

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.

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What we’ll cover

Group

How does FDA use RWE studies to inform approvals?

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What impact does RWE have across therapeutic areas?

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How do RWE studies inform prescribing?

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What factors influenced the success of external control arms?

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How can Aetion help you generate decision-grade RWE?

Enhance your regulatory submissions with RWE.


Download the eBook

Learn about the role of RWE in FDA approvals.

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