US Regulations for Regenerative Medicine and Advanced Therapies
Regenerative therapies could be in the future for eye banking, and with these advancements, there will be new regulations. As eye banks prepare for new technologies such as human corneal endothelial cell (HCEC) cultures, these stem cell therapies would be regulated as both drug and biological products under FD&C Act, and section 351 of the PHS Act regulations. Seth Olson, the FDA/Life Sciences Associate for LATHAM & WATKINS, LLP, compares and contrasts these requirements to prepare organizations for expanded regulations and provides insights for various regulatory pathways.
The presentation will cover FDA’s oversight and requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s) as well as Biological Products, which require a biologics license application (BLA). Seth will discuss at a high level the general data requirements for a BLA, along with other considerations comparing the two regulatory pathways.
J. Seth Olson, JD
Latham & Watkins
Seth Olson, JD, is an associate in the Washington, D.C. office of Latham & Watkins and a member of the Healthcare & Life Sciences Practice. He advises clients on regulatory, compliance, and transactional matters involving the US Food and Drug Administration (FDA) and other federal health agencies, including the medical device, pharmaceutical, biotechnology, human cellular and tissue-based products, food, dietary supplement, and cosmetic industries.