SILVER SPRING, Md (FNN NEWS) – The US Food and Drug Administration (FDA) has announced new steps to increase oversight of clinics and companies offering stem cell therapies in an effort to crack down on “bad actors”.
Recently, the FDA has taken steps in Florida and California to address several “especially troubling” stem cell products being marketed, FDA Commissioner Scott Gottlieb, MD, said in a statement.
FDA Issued Warning Letter To Florida Clinic
The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.
Read Full Statement by FDA Commissioner Scott Gottlieb, MD