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eBook

78% of FDA-approved 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

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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.

2021 eBook cover in tablet

Download the eBook

Learn about the role of RWE in FDA approvals.