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Regenerative Sciences fights FDA charge that its stem cell-based procedure should be classed as a "drug"

This article was originally published in Scrip

Executive Summary

The US FDA is seeking to permanently enjoin Regenerative Sciences, a Colorado-based company, from using a cultured cell product as part of a stem cell procedure known as Regenexx to treat patients with acute orthopaedic ailments (aimed at avoiding surgery). The two sides may be heading for a showdown, as Regenerative Sciences wants to prove in court that it is not a drug manufacturer, but simply a clinic/medical practice that performs procedures; it claims the FDA has overstepped its regulatory authority.

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