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.
Emily Marden, Counsel, Sidley Austin LLP
This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in March 2021.