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USA v. Regenerative Sciences, LLC, et al
Case Number:
12-5254
Court:
Nature of Suit:
-
February 04, 2014
FDA Can Regulate Stem Cell Treatments, DC Circ. Rules
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.
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October 21, 2013
FDA Cannot Regulate Stem Cell Treatments, DC Circ. Hears
Regenerative Sciences LLC on Monday blasted the U.S. Food and Drug Administration's attempt to regulate its stem cell treatments as a drug, telling a D.C. Circuit panel that the agency doesn't have the authority to oversee its medical practices.