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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)
Panelist
Jeffrey Shuren, JD, MD
FDA, United States
Director, Center for Devices and Radiological Health
Panelist
Alberto Gutierrez, PhD
NDA Partners, United States
Partner
Panelist
Christy L. Foreman
Biologics Consulting, United States
Senior Consultant
Panelist
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
Panelist
Michelle Taylor McMurry-Heath, MD, PhD
BIO, United States
President and CEO
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