Post by AESARA

The CFL-SASS Collaborative for #RWE has now completed the Modified Delphi Panel process and finalized the study report and key outputs.​ Through expert discussion and multi-stakeholder consensus, the group developed a set of guiding principles and consensus statements that clarify how real-world evidence (RWE) can meet the scientifically appropriate and statistically sound (#SASS) standard outlined in FDA’s Consistent with Labeling (#CFL) guidance. Practical tools were also created to support implementation across organizations.​ We are now finalizing the manuscript and look forward to presenting the outputs from the Collaborative at ISPOR’s 2026 Annual Conference in Philadelphia. Our Issues Panel session will be held on Tuesday May 19th at 10:30AM.​ This marks an important step forward in advancing transparent, consistent, and credible approaches to RWE communication. We look forward to continuing the conversation at ISPOR 2026 and sharing these insights with the broader community. #AESARA #ValueandAccess #MarketAccess #HEOR #Biopharma #ISPOR2026