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Session 1: The 21st Century Cures Act and PDUFA VI: Highlights and Impact
Session Chair(s)
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States
The 21st Century Cures Act was signed into law December 13, 2016 and the PDUFA VI proposed commitment letter rests with Congressional authorizing committees. The spirit of both legislative documents seeks to enhance the development and approval of drugs and biologics for the benefit of public health. In this session, overviews of the 21st Century Cures Act and PDUFA VI will be presented. The overviews will be germane in understanding the role of statisticians in the implementation of the legislation.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe key components of the 21st Century Cures Act and PDUFA VI
- Assess the impact of the 21st Century Cures Act and PDUFA VI on statistical practice
Speaker(s)
Session Co-Chair
Jerald Schindler, DrPH
Strategic Statistics, United States
Chief Executive Officer
21st Century Cures: Highlights and Expectations
Gregory Daniel, PhD, MPH
Eli Lilly and Company, United States
Global Head of Public Policy, Global Corporate Affairs
PDUFA VI: Highlights and Expectations
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
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