Introduction: The Rising Role of RWE in Regulatory Filings Real-world evidence (RWE) has rapidly transitioned from a supportive tool to a cornerstone of regulatory submissions, spurred by initiatives like the 21st Century Cures Act. This shift reflects a growing recognition of real-world data's (RWD) ability to provide critical insights into treatment effectiveness and safety beyond controlled clinical trial settings. However, navigating the complexities of RWE integration demands adherence to stringent evidentiary requirements and strategic planning. In this post, we’ll explore key best practices for leveraging RWE in regulatory filings, drawing insights from guidance documents to help set you up for success. Why RWE Matters for Regulatory Submissions RWE offers unique opportunities for: Characterizing Disease Burden and Natural History: RWE provides comprehensive data on disease progression and patient outcomes, essential for understanding unmet need. Supporting Label Expansions: As