Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices
A Landscape Assessment
ResearchPosted on rand.org Nov 3, 2021Published in: Value in Health (2021). doi: 10.1016/j.jval.2021.07.003
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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Document Details
- Copyright: ISPOR-The Professional Society for Health Economics and Outcomes Research
- Publisher: Elsevier Inc
- Availability: Non-RAND
- Year: 2021
- Pages: 7
- Document Number: EP-68757
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