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FDASIA Patient Provisions: One Year Later
Program Code:
349
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
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
Executive Vice President and Chief Operating Officer of the National Health Council, an organization that brings together all segments of the health care community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers.
|
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
James Valentine works at FDA's Office of Health and Constituent Affairs, the agency's liaison to patient advocates and health professionals. There he engages with stakeholders on regulatory policy initiatives. James has a bachelor’s degree from UMBC and a master’s in health policy from JHSPH.
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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.