FDA has sent warning letters to companies that process, distribute and offer umbilical cord blood derived products and unapproved stem cell products to patients. FDA also issued a safety alert about exosome products which are not FDA approved and had multiple recent reports of serious adverse events associated with its use.

Public Safety Notification on Exosome Products: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk: https://www.fda.gov/news-events/press-announcements/fda-sends-warning-companies-offering-unapproved-umbilical-cord-blood-products-may-put-patients-risk



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