Introduction to Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Learn the definition of human cellular and tissue-based products (HCT/P) and how to determine whether an HCT/P is regulated solely under regulations issued under Section 361 of the PHS Act. Learn about types of emerging technologies such as cell and gene therapies.
Tina Papagiannopoulos, Counsel, Foley Hoag LLP
Matthew Piscitelli, Associate, Foley Hoag 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 October 2023.