4B: Fast Tracks and Fault Lines: Reassessing FDA’s Market Pathways and Review 

4B: Fast Tracks and Fault Lines: Reassessing FDA’s Market Pathways and Review 

• Holly Fernandez Lynch, Perelman School of Medicine, University of Pennsylvania, FDA’s Accelerated Approval Pathway as a One-Way Ratchet
• Walter G. Johnson, Stanford Law School, Comparing Expedited Review Pathways at the FDA
• Lauren Walsh, University of Pennsylvania, Balancing FDA’s Pre-Approval and Post-Market Review of AI-enabled Medical Products
• Ryan Knox, DePaul University College of Law, Withdrawal of FDA Approval