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Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon
Session Chair(s)
Janet Jenkins-Showalter
Head, US Regulatory Policy
Genentech, A Member of the Roche Group, United States
Following the recent passage of the MDUFA, there will be many challenges ahead to implement the new legislation. This forum will focus on understanding the way forward and the key initiatives for CDRH in the post-user fee reauthorization era. CDRH Senior Staff will discuss their priorities and challenges and provide their perspective on areas that are expected to be the focus of external stakeholders.
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
Christy L. Foreman
Biologics Consulting, United States
Senior Consultant
Panelist
Alberto Gutierrez, PHD
NDA Partners, United States
Partner
Panelist
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States