DIA 2013 49th Annual Meeting
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FDASIA: Impact of New Legislative Provisions on Innovative Drug Development
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
310
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
254AB
CHAIR
:
Janet Jenkins-Showalter, (SCHNON), Senior Regulatory Group Director, Regulatory Policy and Intelligence, Genentech, A Member of the Roche Group, United States
SPEAKER
(S):
Robert J. Temple, MD (SCHAGY), Deputy Center Director for Clinical Science, CDER, FDA, United States Andrew Emmett, MPH (SPKNON), Managing Director, Science and Regulatory Affairs, The Biotechnology Industry Organization (BIO), United States
Diane D. Edquist Dorman, (SPKSUP), Vice President, Public Policy, National Organization For Rare Disorders (NORD), United States
Description
The Food and Drug Administration Safety and Innovation Act (FDASIA) was implemented on October 1, 2012. This session will discuss how regulatory professionals need to understand the terms of the FDASIA provisions and the impact they have on the drug and device development and review process, and effectively assess FDA's progress thus far.
This session is a part of:
This session is a part of: