REAL-WORLD DATA BACK IN THE SPOTLIGHT AT FDA

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On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance. This guidance outlines important considerations for the use of real-world evidence (RWE) in the form of electronic health records (EHRs) and medical claims data in clinical studies, including interventional clinical investigations and observational studies. The guidance finalizes the prior draft guidance issued by FDA in September 2021 with minimal changes, such as clarifications related to use of data sources and discussion of artificial intelligence (AI) technologies.

Stakeholders potentially affected by this guidance include sponsors; sources of EHR or claims data such as EHR vendors, payors and data aggregators; and other interested parties such as developers of AI tools used to curate or analyze such data. These stakeholders should review the guidance and be familiar with its recommendations for leveraging data sources for FDA regulatory decision making.

Full article in link below.

https://www.mwe.com/insights/real-world-data-back-in-the-spotlight-at-fda/