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CDRH Town Hall
Session Chair(s)
Janet Jenkins-Showalter
Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
This forum will provide a unique opportunity to hear from the director of the Center for Devices and Radiological Health (CDRH) who will report on the state of CDRH and its vision for the future. Topics to be addressed include: CDRH's Senior Staff Management Team; FDASIA accomplishments and activities; the view toward 2017 MDUFA Reauthorization and the impact of the House Energy and Commerce 21st Century Cures initiatives; regulatory framework for laboratory developed tests (LDTs); CDRH's development of expedited pathways; the future of next gen sequencing and innovative approaches for companion diagnostics and personalized medicine; human factors studies; combination products; regulation of mobile and web software applications, and other new technologies and their impact on patient care.
Please come prepared with your questions for the CDRH panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diaglobal.org, and include “CDRH Panel” in the subject line.
Learning Objective : Discuss key hot topics for CDRH; Identify priorities and challenges for the future.
Speaker(s)
Panelist
Jeffrey Shuren, JD, MD
Director, Center for Devices and Radiological Health, FDA, United States
Panelist
Alberto Gutierrez, PhD
Partner, NDA Partners, United States
Panelist
Jonette R. Foy, PhD
Deputy Director for Engineering and Science Review, ODE, CDRH, FDA, United States
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