FDASIA Patient Provisions: One Year Later

Track:
Regulatory Affairs and Submissions

Day & Time:
June 26, 1:45PM - 3:15PM

Session Number:
349

Room Number:
254AB

Level:
Basic

Type:
Session

Title:
FDASIA Patient Provisions: One Year Later

Chair(s):
James E. Valentine
Program Analyst, Office of Health and Constituent Affairs, OC
FDA, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
The Patient Perspective
Marc M. Boutin, JD
Executive Vice President and Chief Operating Officer
National Health Council, United States