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Pharmaceuticals / Regulatory Affairs / Inspections and Audits

Gottlieb: FDA Will Increase Inspections of Stem Cell Facilities

Dec. 20, 2018

The FDA will step up enforcement efforts against stem cell clinics in the coming months, Commissioner Scott Gottlieb told participants at the FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C., on Wednesday.

The agency took enforcement action against two stem cell clinics this year to stop them from marketing products without the appropriate FDA approvals, Gottlieb said in his keynote address. “While cell-based regenerative medicine holds significant medical promise, we’ve seen bad actors leverage that scientific opportunity to peddle unapproved treatments that put patients’ health at risk,” he said.

Gottlieb said the agency is “going to be putting many more firms on notice that we’re aware that they’re manufacturing cell and tissue products that are subject to our oversight.”

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