FDA Can Regulate Stem Cell Treatments, DC Circ. Rules

Law360, Los Angeles (February 4, 2014, 5:00 PM EST) -- The D.C. Circuit on Tuesday ruled that Regenerative Sciences LLC's stem cell treatment is a drug and therefore subject to U.S. Food and Drug Administration regulations, rejecting the company's claims that its process is a medical procedure subject to state laws.

The appeals court affirmed a district court’s orders granting summary judgment and an injunction to the government just three months after Regenerative Sciences blasted the FDA’s attempt to regulate the Regenexx procedure, which uses a patient's stem cells mixed with an antibiotic to treat joint, muscle,...
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Case Information

Case Title

USA v. Regenerative Sciences, LLC, et al

Case Number



Appellate - DC Circuit

Nature of Suit

1890 Other Statutory Actions

Date Filed

August 16, 2012

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