Potential risks of treatment with unapproved regenerative medicine products

FDA

22 July 2020 - Protecting patients is at the core of what we do at the U.S. Food and Drug Administration. 

Now the FDA is providing additional resources to help consumers understand the risks associated with unapproved stem cell, exosome, and other products marketed as regenerative medicine products. The agency is also facilitating the reporting of side effects that may occur after their use. 

The FDA’s receipt of this information is important to developing a better understanding of the risks associated with these products and to helping the agency identify those clinics and manufacturers putting patients at risk.

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Michael Wonder

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Michael Wonder