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Update from CBER: Advancing the Development of Complex Biologic Products
Session Chair(s)
Peter W. Marks, MD, PhD
Director, Center for Biologics Evaluation and Research
FDA, United States
This session will provide an overview of how the Center for Biologics Evaluation and Research (CBER) works to advance the development of complex biological products such as vaccines, live biotherapeutics, and cellular and gene therapies. The session will include a discussion of how the Center is working to implement relevant provision of the 21st Century Cure Act aimed at further expediting the development of important medical products.
Learning Objective : Identify regulatory work recently completed or in progress and communicate Center priorities for the coming years.
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