Bloomberg Law
June 1, 2021, 9:01 AM

FDA to Crack Down on Stem Cell Clinics With Unproven Therapies

Jeannie Baumann
Jeannie Baumann

Hundreds of U.S. stem cell clinics selling experimental therapies without an FDA permit can expect to face the agency’s enforcement arm and potential action from the federal government.

The Food and Drug Administration ended a three-and-a-half year grace period Monday designed to allow these clinics to come into compliance with its 2017 regenerative medicine policy. The agency has worked with federal law enforcement agencies to shut down the most egregious cases, including one that made several women blind.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has made clear for years that the agency ...

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