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Lapsing Stem Cell Grace Period Signals Tougher FDA Enforcement

April 2, 2020, 7:56 PM

Companies selling unproven stem cell treatments are more likely to face the FDA’s enforcement arm come November, the agency’s biologics director said.

The Food and Drug Administration targeted the most egregious violations as part of a 2017 regulatory framework. Companies had three years under that framework to comply with FDA regulations, an window that will close Nov. 20.

“Although we don’t generally discuss our enforcement and compliance policies, I can say that, after that time, if people aren’t in compliance, they are at risk of having us come,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and ...