The US Food and Drug Administration (FDA) last month published draft guidance on the use of electronic health records (EHRs) and claims data to support regulatory decision making.

“Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products” is part of the FDA’s series of guidances to satisfy the real-world evidence provisions of the 21st Century Cures Act. The guidance provides recommendations on the use of real-world data gathered from EHRs and claims data to support regulatory decisions about effectiveness and safety. It addresses selection of data sources, development and validation of definitions for study design elements, and data provenance and quality.

The comment period for the draft guidance ends on November 29, 2021.