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.