Regenerative Medicine and Advanced Therapies: An Introduction

Distinguish between human cellular and tissue-based products (HCT/P). Review the regulatory framework for the regulation of regenerative medicine products and discuss key definitions and eligible therapies. Examine expedited programs for RMATs. Review emerging issues in gene editing, in-office procedures and stem cell manufacturing practices.

Nathan Beaton, Associate, Latham & Watkins LLP

This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in March 2022. 


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