FDA Can Regulate Stem Cell Treatment As Drug, DC Circ. Hears

Law360, Los Angeles (March 13, 2013, 4:51 PM EDT) -- The U.S. Food and Drug Administration told the D.C. Circuit that Regenerative Sciences LLC's stem cell treatment is a drug and therefore subject to its regulations, saying a lower court had ruled correctly on the question in the drug company's suit challenging the agency's right to regulate the treatment.

In a brief filed with the D.C. Circuit Wednesday, the FDA said U.S. District Judge Rosemary M. Collyer was justified in ruling that Regenerative Sciences’ Regenexx procedure, which uses a patient's stem cells mixed with other components...
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