A new turn in FDA versus Regenerative Sciences lawsuit

by Alexey Bersenev on July 26, 2012 · 0 comments

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Since 2008 we are precisely follow the litigation between US company Regenerative Sciences and FDA. A big question, which underlies this lawsuit – are cultured autologous stem cells drugs? In other words – Is autologous stem cell therapy practice of medicine? This week, the long-term lawsuit got a new turn. The court ruled in favor of FDA, therefore supported FDA regulation of adult stem cells as drugs. There is a massive coverage of this event on the blogs. There are some discussions and interesting opinions. I summarize the coverage of this story below:

Federal court gives FDA explicit power to regulate stem cells as drugs: start of new era? (Knoepfler Lab Stem Cell Blog)
Ruling frees FDA to crack down on stem cell clinics (New Scientist)
FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012) (Cell Therapy Blog)
The Regenerative Sciences – FDA Court Struggle Ends . . . For Now (FDA Law Blog)
U.S. Federal Court Says Stem Cell Treatments Are Drugs (ScienceInsider)
Refuting potential downsides to stem cell drug court ruling (Knoepfler Lab Stem Cell Blog)
Court ruling: FDA can regulate stem cell clinics (Nature News blog)
U.S. District Court rules that stem cells are drugs (Scope blog)

Summary of tweets on Storify:

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