The FDA Continues Its Effort to Reign in Rogue Stem Cell Therapy Companies
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
On August 28, 2017, the U.S. Food and Drug Administration (“FDA”) issued a scathing Warning Letter to a U.S. Stem Cell Clinic 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. Although the FDA Warning Letter was directed to a specific stem cell company, many observers note the FDA’s more extensive and broader efforts to regulate, enforce, and otherwise ensure compliance with good stem cell practices and procedures.