FDA | What's New Follow Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned - 09/23/2025 Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23, 2025 http://www.fda.gov/news-events/speeches-fda-officials/regulatory-submissions-real-world-evidence-successes-challenges-and-lessons-learned-09232025 fda.gov