Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry July 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory?utm_medium=email&utm_source=govdelivery FDA issued the final guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. The guidance includes recommendations for sponsors and other interested parties proposing to use data from electronic health records (EHRs) or medical claims to help support a new use of an FDA-approved drug or biological product or to help support or satisfy post-approval study requirements. FDA issued the draft version of the guidance in September 2021 and considered public comments when finalizing the guidance. Changes from the draft to the final guidance include: clarifying the considerations for selecting study variables for validation, and the extent of effort needed for validation; noting that choice of a reference standard for validation may vary according to study-specific factors; recommending the use of quantitative approaches to demonstrate whether and how study findings might be impacted if certain key study variable(s) are misclassified; and removing from the glossary defined terms that are generally understood and transferring other relevant definitions from the glossary to the text in the guidance.