Session (CTI)

ISSUE: Real-world evidence (RWE) is now central to demonstrating the value of medicines, yet one of the field’s greatest challenges remains: how to communicate RWE compliantly, transparently, and impactfully to the decision makers who rely on it. FDA’s Consistent with FDA-Required Labeling (CFL) pathway offers a mechanism to do this, but uncertainty around what constitutes “scientifically appropriate and statistically sound” (SASS) evidence has limited its use. OVERVIEW: This panel session will introduce the CFL-SASS Principles by Expert Consensus for RWE, the first multi-sponsor, expert-driven effort to clarify methodological and regulatory expectations for generating and communicating RWE under the CFL pathway. Speakers will each take 10 minutes to present the perspectives noted above, followed by questions for discussion and audience interaction. Attendees will learn about: a) Why dissemination—not generation—is now the critical bottleneck for RWE impact b) The opportunities and challenges of applying CFL-SASS evidence standards for RWE c) The expert consensus recommendations addressing methodological and regulatory issues d) How this work can strengthen internal review, improve evidence transparency, and elevate HEOR’s role in informing access and reimbursement decisions The session will feature leading RWE, regulatory, and HEOR experts in a lively, interactive discussion on how this initiative can help the field unlock the full value of RWE