5 Takeaways & An Overview of FDA's Guidance on Assessing Electronic Health Records and Medical Claims Data for Regulatory Decision-Making

FDA released their updated and final guidance on Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making on July 25, 2024. The guidance does not endorse specific data sources, study methodologies, or standards. Instead, it provides insight into the FDA’s concerns and considerations so sponsors can address these when conducting studies using data from EHRs and medical claims.