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On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations following a back-and-forth between FDA and Akan. The Form FDA-483 highlights a number of observations about 585 vials of an Akan product, but the warning letter spends considerable time beforehand covering reasons why Akan’s product does not meet the requirements of 21 C.F.R. § 1271.10(a), which qualify certain human cells, tissues, or cellular or tissue-based products (HCT/Ps) for exemptions from key FDCA requirements, including premarket review. Akan’s product is an adipose derived, stromal vascular fraction (SVF) cellular product for allogenic use with the brand name Ayama™.Continue Reading FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

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

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas)[1] for marketing human cells, tissues, or cellular or tissue-based products (HCT/Ps)[2] without FDA premarket review. The letter described Thomas’ marketing of products derived from human umbilical cord, umbilical cord blood and amniotic tissue as “regenerative therapy solutions” or “stem cell derived biological product” to treat various diseases and conditions including cardiac disease, Alzheimer’s, Parkinson’s, lung disease, diabetes and COVID-19.Continue Reading FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer