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/.
- 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 ...