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PDUFA VII: A Vital Reauthorization

Please join Research!America for a webinar “PDUFA VII: A Vital Reauthorization.” An experienced panel will discuss the Prescription Drug User Fee Act’s (PDUFA) history, impact, and policy issues that may arise during the reauthorization process. Topics will include patient focused drug development, real world evidence, advanced manufacturing, and gene and cell therapies.

PDUFA is a landmark piece of legislation that transformed the Food and Drug Administration’s (FDA) ability to assure the safety and efficacy of therapeutic drugs. The next reauthorization of the law must be passed by Congress and signed by the President by September 30, 2022.

Watch the Recording


Jenny Luray, Vice President of Strategy and Communications, Research!America


  • Clay Alspach, Principal, Leavitt Partners
    • Former Chief Health Counsel, House Energy & Commerce Committee
  • Remy Brim, Principal, Co-head, Health and Life Sciences Practice, BGR Group
    • Former FDA Policy Advisor, Senate HELP Committee
  • 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
    • Former FDA Commissioner
  • John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health
    • Former Acting Deputy Commissioner and Counselor to the Commissioner