FDA Issues Public Safety Notification Regarding Exosome Products

Published 2020-01-02

On December 6th, 2019, FDA issued a public safety notification regarding Stem Cell derived exosome products. FDA cited "multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes". FDA goes on to state that "there are currently no FDA-approved exosome products" and outlines that exosome products do fall under the umbrella of drugs and biologics.

Search our Directory

AABRM Members are not only experts in regenerative medicine but offer a wide range of related products, services and related-procedures in that field. Search our extensive Member Directory to find a Member near you.

Member Directory

American Society of Regenerative Medicine Logo

Excellence.  Education.  Research.  Practice.