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Home » CMS drafts guidance for use of real-world data in CED studies
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CMS drafts guidance for use of real-world data in CED studies

Jan. 21, 2025
By Mark McCarty
Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
BioWorld MedTech Regulatory U.S. CMS

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