FDASIA: Impact of New Legislative Provisions on Innovative Drug Development

Track:
Regulatory Affairs and Submissions

Day & Time:
June 26, 8:00AM - 9:30AM

Session Number:
310

Room Number:
254AB

Level:
Intermediate

Type:
Session

Title:
FDASIA: Impact of New Legislative Provisions on Innovative Drug Development

Chair(s):
Janet Jenkins-Showalter
Senior Regulatory Group Director, Regulatory Policy and Intelligence
Genentech, A Member of the Roche Group, 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.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
FDA Point of View
Robert J. Temple, MD
Deputy Center Director for Clinical Science, CDER
FDA, United States

BIO Point of View
Andrew Emmett, MPH
Managing Director, Science and Regulatory Affairs
The Biotechnology Industry Organization (BIO), United States

NORD Point of View
Diane D. Edquist Dorman
Vice President, Public Policy
National Organization For Rare Disorders (NORD), United States