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FDA Regulation of Therapeutic Products Derived from Human Stem Cells: Successfully Navigating the Regulatory Hurdles
Session Chair(s)
Torrey Cope, JD
Partner
Sidley Austin LLP, United States
FDA regulates many types of therapeutic products derived from human stem cells as biological drugs. This forum will address the basic regulatory requirements for these products, common hurdles that arise in research and development, and options for addressing those hurdles.
Learning Objective : Describe the general FDA framework governing therapeutic products derived from human stem cells including common regulatory hurdles associated with the research and development of such products; Identify and plan for successful management of specific regulatory issues that are likely to affect development of a specific stem cell product.
Speaker(s)
Panelist
Ellen G Feigal, MD, MSc
NDA Partners LLC, United States
Principal
Panelist
Rachel Smith
Capricor Therapeutics, Inc., United States
Vice President, R&D
Panelist
Darin J. Weber, PhD
Mesoblast, Inc. , United States
Global Regulatory Affairs & Quality Management
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