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.

Gail Javitt, Partner, Hyman, Phelps & McNamara, PC 

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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