There is plenty of high-level guidance on real-world evidence (RWE) use in regulatory submissions, but sponsors are often left wondering how to put those recommendations into practice. What does it take to transform complex real-world data (RWD) into regulatory-ready RWE? What can be done to help regulators trust your evidence—and approve your submission? We developed a clear step-by-step framework for the preparation of RWD for regulatory submission based on an in-depth review and synthesis of current FDA guidance and regulator feedback to real-world submissions containing RWE. Key steps include: Want to learn more about preparing RWD for regulatory review? Connect with our team to explore how to apply our framework to your next submission, or explore our other RWE services.

Despite growing interest in using real-world evidence (RWE) in regulatory approvals, limited information is available about how these guidelines have been applied in practice. Our targeted literature review and case series of drug applications containing RWE (2021-2023) suggests RWE use is still often limited to first-in-class treatments for orphan indications. It seems that regulators are be receptive to RWE in principle, but successful drug applications appear to rely on the entire body of evidence, including indication, methodological rigor, and the use of effective, transparent, and fit-for-purpose RWE. While the FDA has long used RWE for post-approval monitoring and evaluation, use of RWE for BLAs/NDAs has typically been limited to rare disease indications. The FDA, along with global regulatory bodies, have issued guidelines about RWE incorporation into a wider range of regulatory submissions. However, our findings suggest ongoing uncertainty about how to leverage RWD effectively

Happy Summer! Our July roundup spotlights what’s working (and what’s still missing) when it comes to real-world evidence. We’re covering trends in regulatory use, a step-by-step framework for reviewer-ready RWD, and a real-world look at Wegovy® use and outcomes after a change in public insurance coverage. Plus, we’ll be presenting at ISPE next month—let’s connect! ** Great Potential, Limited Practice: RWE Use in FDA MAAs Limited to Orphan Drugs Despite growing interest in using real-world evidence (RWE) in regulatory approvals, limited information is available about how these guidelines have been applied in practice. Our targeted literature review and case series of drug applications containing RWE (2021-2023) suggests RWE use is still often limited to first-in-class treatments for orphan indications. It seems that regulators are be receptive to RWE in principle, but successful drug applications appear to rely on the entire body of evidence, including indication, methodological rigor,

Landmark Science Makes RWE Services for Biopharma Industry a Boutique Experience

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

Humbi AI by Innovaccer and Landmark Science to Present Real-World Evidence on GLP-1 Use for Cardiometabolic and Cardiovascular Risk Reduction in Medicare Populations at ISPOR 2025