FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023

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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……
By: Sheppard Mullin Richter & Hampton LLP
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