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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: FDASIA accomplishments and activities; the view toward 2017 MDUFA Reauthorization; companion diagnostics and personalized medicine; investigational device exemptions for in vitro diagnostic products (including companion diagnostic products); FDA’s Unique Device Identification (UDI) program; regulation of mobile and web software applications; CDRH’s Case-for-Quality Initiative – promoting device quality in the global marketplace; and public-private partnerships, ie, Medical Devices Innovation Consortium (MDIC) and other CDRH innovative programs.
Please come prepared with your questions for the CDRH panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.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)
Jeffrey Shuren, JD, MD
Director, Center for Devices and Radiological Health, FDA, United States
Panelist
Alberto Gutierrez, PHD
Partner, NDA Partners, United States
Panelist
Christy L. Foreman
Senior Consultant, Biologics Consulting, United States
Panelist
Kirsten H. Paulson, MS, RAC
, Pfizer, Inc., United States
Panelist
Michelle Taylor McMurry-Heath, MD, PHD
President and CEO, BIO, United States
Panelist
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