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FDASIA: Impact of New Legislative Provisions on Innovative Drug Development
Session Chair(s)
Janet Jenkins-Showalter
Head, US Regulatory Policy
Genentech, A Member of the Roche Group, United States
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.
Learning Objective : Identify the specific terms of the provisions included in FDASIA; Identify FDA’s progress in carrying out these provisions; Discuss the impact that the provisions have on the overall drug and device development and review process, regulatory efficiency and patient access.
Speaker(s)
FDA Point of View
Robert J. Temple, MD
FDA, United States
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
BIO Point of View
Andrew Emmett, MPH
Pfizer, United States
VP, Global Regulatory Policy and Global Intelligence
NORD Point of View
Diane Edquist Dorman
dDConsulting LLC, United States
Patient Advocacy Expert