Cellular therapy laboratory (CTL) products include HCT/Ps, licensed products and products manufactured under IND/IDE used to support clinical studies. These different classifications affect several aspects of a CTL's regulatory responsibilities. This session will provide practical information associated with CT regulations in the age of licensed CT products. From a technical perspective, the CTL can thaw and wash cord blood units prior to infusion. However, from a regulatory perspective, is this process considered manufacturing if the product is licensed? Can the laboratory perform their own validated thaw procedure or must they follow the manufacturer's instructions? Who is really the manufacturer' and how are FDA reporting requirements impacted since different product types (IND, 361, 351) have different regulatory reporting requirements. Attend this session to learn who is responsible for reporting based on the product and its intended use.