Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices

A Landscape Assessment

Published in: Value in Health (2021). doi: 10.1016/j.jval.2021.07.003

Posted on on November 03, 2021

by Justin W. Timbie, Alice Y. Kim, Thomas W. Concannon

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Real-world evidence (RWE) (as opposed to evidence from clinical trials) is an underutilized resource to support FDA processes and pharmaceutical regulations. Stakeholder interviews suggested the RWE has a role to play, but there are concerns about its rigor.

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