Comment from AISHA HASSAN-DAVIS

As a healthcare provider, I support the FDA's efforts to establish clear standards for using real-world data from electronic health records and medical claims databases. These data sources reflect how medications perform in routine clinical practice and can provide valuable information that may not be fully captured in traditional clinical trials. High-quality real-world evidence can improve regulatory decision-making, enhance patient safety, and accelerate access to effective treatments. I encourage the FDA to continue emphasizing data quality, transparency, and validation when evaluating real-world data sources. Accurate, reliable information is especially important for patients with chronic medical and mental health conditions, who are often underrepresented in clinical trials. Thoughtful use of electronic health records and claims data can help identify treatment outcomes, medication safety concerns, and long-term effectiveness across diverse patient populations. Overall, I believe this guidance is an important step toward integrating real-world evidence into evidence-based healthcare and regulatory decision-making.