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Some stem cell products are not FDA certified

US companies received a warning from the FDA for selling stem cell products without approval

10-Dec-2019

Key points from article :

FDA has strict regulations regarding which products derived from umbilical cord blood can receive approval.

Companies were unlawfully harvesting, processing, and selling umbilical cord blood-derived products.

Products called PURE and PURE PRO has obtained no licenses.

RichSource Stem Cells and Chara Biologics were selling unapproved stem cell products.

Resulting products may have been contaminated with viruses or other potentially dangerous microorganisms.

Companies who violated the rules could put people who used these products at very serious risk.

FDA has also issued a safety alert about exosome products.

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Peter Marks

Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration

Topics mentioned on this page:
Stem Cells