11:30

Session 3: Substantive Issues

Moderator

Richard A. Merrill

Daniel Caplin Professor of Law and Sullivan and Cromwell Research Professor of Law, University of Virginia Law School

Influential

Robert C. Ashby

Deputy Assistant General Counsel for Regulation and Enforcement

Office of General Counsel

U.S. Department of Transportation

SDWA:Adopt/Adapt

Jane A. Axelrad

Associate Director for Policy

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

12:10

Questions/Comments

12:30

Lunch/Adjourn



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