PDUFA VII: A Vital Reauthorization

An experienced panel joined us for an off-the-record discussion on the Prescription Drug User Fee Act's (PDUFA) history, impact, and policy issues that may arise during the reauthorization process. Topics included patient focused drug development, real world evidence, advanced manufacturing, and gene and cell therapies.
Moderator:
Jenny Luray, Vice President of Strategy and Communications, Research!America
Panelists:
Clay Alspach, Principal, Leavitt Partners
Remy Brim, Principal, Co-head, Health and Life Sciences Practice, BGR Group
Annie Kennedy, Chief of Policy, Advocacy, & Patient Engagement, EveryLife Foundation for Rare Diseases
Mark McClellan, Director, Robert J. Margolis Center for Health Policy at Duke University
John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health