Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned September 23, 2025 — 9:30AM–3:00PM

https://healthpolicy.duke.edu/events/regulatory-submissions-real-world-evidence-successes-challenges-and-lessons-learned?utm_medium=email&utm_source=govdelivery Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned Date: Tue, Sept. 23, 2025; 9:30 a.m. - 3 p.m. ET During this meeting, experts will discuss lessons learned from case studies in which RWE was used for regulatory decision-making for medical products. Speakers will highlight FDA’s efforts with RWD/E to date and approaches to generate RWE to meet regulatory requirements. This convening fulfills both a PDUFA VII and a MDUFA V requirement. https://lp.constantcontactpages.com/ev/reg/8u7ymaa?utm_medium=email&utm_source=govdelivery