DIA 2013 49th Annual Meeting
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FDASIA Patient Provisions: One Year Later
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 349
Date: Wednesday, June 26, 2013
Time: 1:45 PM to 3:15 PM  EST
Location: 254AB
CHAIR :
James E. Valentine, (SCHAGY), Program Analyst, Office of Health and Constituent Affairs, OC, FDA, United States
SPEAKER (S):
 Marc M. Boutin, Esq, JD (SPKSUP), Executive Vice President and Chief Operating Officer, National Health Council, United States
Diane D. Edquist Dorman, (SPKSUP), Vice President, Public Policy, National Organization For Rare Disorders (NORD), United States
 James E. Valentine, (SPKAGY), 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.