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FDASIA Patient Provisions: One Year Later
Session Chair(s)
James Valentine, JD, MHS
Director
Hyman, Phelps & McNamara, PC, United States
The Food and Drug Administration Safety and Innovation Act (FDASIA) included provisions that enhanced patient input into FDA decision-making. This session will provide an overview of these patient provisions and a one year update on implementation from FDA, as well as an assessment from the patient community.
Learning Objective : Identify the patient input provisions established in FDASIA; Explain the progress FDA has made in implementing the patient provisions; Discuss how the enhanced inclusion of the patient perspective will impact FDA medical product regulation.
Speaker(s)
PDUFA V's Patient-focused Drug Development
Marc M. Boutin, JD
Novartis , Switzerland
Global Head of Patient Engagement and Advocacy
FDASIA's Orphan Product Provisions
Diane Edquist Dorman
dDConsulting LLC, United States
Patient Advocacy Expert
An Update on FDASIA Section 1137: The Patient Provision
James Valentine, JD, MHS
Hyman, Phelps & McNamara, PC, United States
Director