Artificial Intelligence and FDA Oversight: Where We Are Now

March 26, 2025 | 9:00 AM–1:30PM | In-Person & Virtual Event

Overview

Artificial intelligence (AI) is transforming healthcare, impacting everything from medical devices and clinical decision support (CDS) to drug application submissions. This half-day virtual conference will explore FDA’s evolving approach to regulating AI in this broad context. Experts will discuss AI-enabled medical devices; CDS software; the use of AI in pharmaceutical research and development (R&D); and data privacy issues, including state, federal, and international regulations on clinical data use. Panelists also will provide practical data management tips.

Sponsors

Gold

Planning Committee

Program Advisor

Mark Gardner, Gardner Law 

Committee Members

Ty Kayam, CDRH, FDA
Stefanie Kraus, CDER, FDA
Sonia Nath, Cooley LLP
Jonathan Trinh, Wilson Sonsini Goodrich & Rosati
Charlotte Tschider, Loyola University Chicago
Benjamin M. Zegarelli, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.