Introduction to Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
A session from FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies
Recorded March 5–6, 2024
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 Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.
TINA PAPAGIANNOPOULOS assists clients with a variety of regulatory, policy, and compliance matters related to the U.S. Food & Drug Administration (FDA) and the Federal Trade Commission (FTC), with a primary focus on therapeutics. She advises clients about product development and regulatory approval, marketing exclusivities, advertising and promotion, post-approval obligations, and responding to enforcement actions and investigations. She counsels clients on effective engagement with the FDA through formal agency meetings as well as through public comment and petitioning processes. She also provides subject-matter expertise on various litigation and transaction matters involving life sciences companies.
MATTHEW PISCITELLI is a member of Foley Hoag’s FDA Group where he advises clients who develop a wide range of products, with an emphasis on manufacturers of medical devices, drugs, and biological products. Matthew counsels clients in regulatory matters across all stages of the product life cycle, from research and development to nonclinical testing, clinical trials, premarket clearance and approval, manufacturing, labeling compliance, and post-market surveillance. Matthew represents clients across a broad range of agency proceedings such as Orange Book listing disputes, citizen petitions, establishment inspections, and enforcement actions. Matthew has extensive experience in conducting regulatory due diligence on behalf of companies seeking to acquire or invest in companies with a portfolio of FDA-regulated products.Get Access
-
+$100 for nonmembers
Internet Explorer and Microsoft Edge are not supported by the checkout process.
Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.
Virtual Learning FAQ
Related Content
