Header graphic for print
Focus on Regulation

Category Archives: Regenerative Medicine

Subscribe to Regenerative Medicine RSS Feed

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell Treatment Center, alleging the treatments seriously harmed patients. Both lawsuits follow up on prior actions that FDA initiated against these

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing Practice (GMP) violations observed during FDA’s  July 2017 inspection of American CryoStem’s New Jersey facility.  In a related press release, the agency cited the

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies.  This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,