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.