This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates, including new Agency level initiatives.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Artificial IntelligenceEvidence Innovation
Learning Objectives
Describe FDA's current AI and RWE regulatory frameworks and key guidance documents and how these align with FDA’s mission; Identify the promise and the limitations of AI in the context of drug and biologics development and identify opportunities for integrating AI and RWE approaches; Apply FDA recommendations for use of AI/RWE in regulatory submissions.
