Stem Cell Letter Could Signal New FDA Enforcement Trend

Law360, New York (January 21, 2016, 9:38 PM EST) -- Mark Mansour

Chistopher M. Mikson

Emily K. Strunk The U.S. Food and Drug Administration has sent a warning letter covering three physician-operated stem cell treatment centers in California, Florida and New York asserting that the centers have unlawfully recovered and processed adipose (fat) tissue to perform stem cell therapy and deviated from current good manufacturing practice (CGMP) and current good tissue practice (CGTP) in doing so. The issuance of a warning letter in these circumstances is significant because it may signal a departure from the FDA's past practice of less strict regulatory enforcement against practitioners of stem cell therapies.

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