Some FDA guidances take several years to finalize, while others move through the process more rapidly. The guidance on "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products" falls into the latter category, progressing from draft to final form in less than three years. This relatively quick turnaround reflects the urgency and importance of establishing clear guidelines for the use of real-world data (RWD) in regulatory decision making. Released a few days ago, this final guidance is part of the FDA's Real-World Evidence (RWE) program, mandated by the 21st Century Cures Act. It provides recommendations for sponsors and researchers on using electronic health records (EHRs) and medical claims data in clinical studies to support regulatory submissions. The guidance addresses key aspects of RWD utilization, including: 1. Evaluation of data source relevance and reliability 2. Development of study design elements 3. Methods for exposure and outcome assessment and validation 4. Approaches to covariate identification and handling 5. Data quality assurance throughout the data lifecycle Emphasizing the need for rigorous methodology, the document outlines strategies for validating study elements, addressing potential biases, and ensuring data quality. It acknowledges the inherent limitations of RWD sources and provides frameworks for mitigating these challenges. This guidance is a significant step in establishing standards for RWD use in regulatory contexts. It aims to facilitate more efficient evidence generation while maintaining scientific integrity. Implementation will require multidisciplinary expertise and investment in data curation and analysis capabilities. Thanks to LLMs and advances in AI since the publication of the original draft guidance, we have more opportunities today for improving RWD quality and integrity. fda.gov/regulatory-informati…