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Tag: homologous use

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

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Yesterday, October 27th, the Feds filed a notice of appeal of Judge Jesus Bernal’s decision awarding Cell Surgical Network and their founders, the late Mark Berman and Eliot Lander, judgment in the FDA’s attempt to shut them down for their SVF (stromal vascular fraction) stem cell treatment. Of course, the feds were going to appeal. Contrary to the Florida district court and the Eleventh Circuit in the US Stem Cell case, Judge Bernal found that SVF was not more than…

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Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

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As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s. The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate. Based on recent FDA action against a couple of these clinics (see my prior post at http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/),the tea leaves weren’t looking good for the FDA loosening-up the rules in the final version. Well,…

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FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy

FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy

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Today was a good day for people who want continued access stem cells outside of clinic trials, and also for people who want the FDA to allow faster access to this promising technology. There was a wide spectrum of opinions. Some stem cell companies involved in clinical trials wanted the non-clinical trials clinics shut down. But at least there were representatives from some of these “unproven” clinics and interest groups who made some important points about the rights of patients…

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