New eBook: The role of RWE in regulatory approvals. Download here.

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


78 percent of FDA approvals for new drugs and biologics in 2020 included a real-world evidence (RWE) study to provide evidence of safety and/or effectiveness.

As industry prepares for additional guidance from FDA on the use of real-world evidence (RWE), Aetion conducted a systematic review of FDA approval documents to understand the role RWE can play to inform regulatory decisions. This 2021 update of our eBook will guide you through when, where, and how RWE studies influenced 2020 approvals.

Download here.

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