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FDA Forum
Session Chair(s)
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
The FDA Forum will focus on inter-center collaboration between CDER, CDRH, CBER, and the Office of Combination Products. The recently established Oncology Center of Excellence will be highlighted as a new area of collaboration. FDA representatives will share how they collaborate to provide advice regarding products in development, review marketing applications, and help accelerate medical product approvals.
Learning Objective : Discuss how the various centers in FDA collaborate to provide advice regarding products in development, review marketing applications, and help accelerate medical product approvals.
Speaker(s)
Panelist
Peter W. Marks, MD, PhD
FDA, United States
Director, Center for Biologics Evaluation and Research
Panelist
Angela Krueger
FDA, United States
Acting Deputy Director, Office of Device Evaluation, CDRH
Panelist
Douglas C. Throckmorton, MD
FDA, United States
Deputy Center Director for Regulatory Programs CDER
Panelist
Tamy Kim, PharmD
FDA, United States
Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence
Panelist
Paul Kluetz, MD
FDA, United States
Deputy Director, Oncology Center of Excellence, OC
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