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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.