RWD109 The Use of Real-World Evidence in FDA Regulatory Submissions: A Review

Abstract

Real-world evidence (RWE) has played a growing role in supporting clinical trial designs and has increasing implications in regulatory decision-making for new and expanded indication approvals, coverage decisions, and post-market safety monitoring. In December 2018, the FDA issued a framework for the agency’s RWE program. The agency has since issued several guidance documents on types of RWE and considerations for using RWE to support regulatory decisions and data standards for submitted real-world data (RWD). This review evaluated examples of RWE in regulatory submissions to the FDA following the issuance of the framework to provide a recent understanding of how RWE has been utilized to support new regulatory submissions and the resulting feedback from agency review.