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FDA Warns Company to Stop Selling Unapproved Stem Cell Therapies

June 4, 2019, 4:40 PM

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

R3 Stem Cell LLC

  • Issuing Office: Food and Drug Administration, Center for Biologics Evaluation and Research
  • Recipient: David Greene (chief executive officer)
  • Date: May 28 (posted May 30)
  • Review of company website at https://r3stemcell.com/.

Alleged Infractions

  • Marketed unapproved stem cell products as “regenerative therapies” to treat a variety of diseases including diabetes, Parkinson’s disease, stroke, kidney failure, and amyotrophic lateral sclerosis.
  • Marketed drugs without demonstrating they were safe and effective for their intended uses.
  • Marketed drugs that are also biological products ...

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