Culturing enough to make stem cells subject to FDA authority
By Mari Serebrov
Thursday, February 6, 2014
A culturing process designed to determine the growth and biological characteristics of the resulting cell population is enough to render stem cells a drug subject to FDA manufacturing and labeling regulations, a federal appellate court said this week in a ruling upholding a permanent injunction against Regenerative Sciences LLC’s Regenexx-C, a stem cell product used as an alternative to surgery for various orthopedic conditions and diseases.
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