#613: FDA Rare Disease Town Hall

Wednesday, June 17, 2026 10:15 AM to 11:30 AM · 1 hr. 15 min. (America/New_York)
201AB
02: ClinicalTrialOps-Innovation08: RegPolicy-Strategy-GlobalCollaboration

Information

Senior FDA leaders will discuss evolving regulatory trends in rare disease development, including accelerated approval, innovative trial designs, patient engagement, and real-world evidence, followed by open Q&A with attendees.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Student and Early Career PathwayTherapeutic Pathways
Learning Objectives
Identify current FDA regulatory trends and scientific approaches shaping rare disease drug development; Apply FDA expectations around accelerated approval, surrogate endpoints, and innovative trial designs; Integrate patient voice and real-world evidence into development strategies to support benefit-risk assessment.

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