To embed, copy and paste the code into your website or blog: On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they needed to file an investigational new drug application (IND) or marketing application with FDA, will conclude at the end of the month. The decision comes as a surprise to some in the industry that speculated the agency may provide further reprieve due to challenges presented by the ongoing COVID-19 pandemic. However, others in the industry appear less surprised given the agency’s prior admonishment of unapproved regenerative medicine products marketed as COVID-19 treatments, which were called “uncontrolled experimental procedures” in a JAMA article by then-FDA Commissioner Stephen Hahn, M.D., and Dr. Marks in June 2020.