Judge Rules FDA Can Regulate Stem Cell Treatment As Drug

Law360, New York (July 24, 2012, 2:08 PM EDT) -- A Washington federal judge on Monday threw out a suit against the U.S. Food and Drug Administration challenging its regulation of a stem cell treatment, finding the procedure constitutes a drug and is subject to FDA enforcement.

While acknowledging that it was a “close question,” U.S. District Judge Rosemary M. Collyer granted summary judgment in favor of the FDA in a suit brought by Regenerative Sciences LLC over the company's trademarked Regenexx Procedure, which uses patients' stem cells from their own bone marrow to treat joint,...
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Case Information

Case Title

UNITED STATES OF AMERICA v. REGENERATIVE SCIENCES, LLC et al


Case Number

1:10-cv-01327

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Rosemary M. Collyer

Date Filed

August 6, 2010

Government Agencies

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