On May 22, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) issued an untitled letter to AT Venture Center for Global Techtrepeneurship, LLC dba Regenerelle, LLC (Regenerelle) for marketing human cells, tissues, or cellular or tissue-based products (HCT/Ps) and exosomes without FDA premarket review. The letter described Regenerelle’s marketing of products derived from umbilical cord as “biological solutions” or “biologic products” that are “intended for a ‘range of clinical applications’ and to treat various diseases or conditions, such as lupus, pain, inflammation, and ‘aging-associated diseases.’” This is CBER’s fourth untitled letter this year, illustrating FDA’s focus on this area of enforcement. This stands in contrast to FDA’s work on the CDER side, where the Office of Prescription Drug Promotion has not issued an untitled letter since June 2, 2022.[1]Continue Reading FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023