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Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

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Here is where the case stands as of September 13, 2021: Closing arguments were held on August 20th. The Judge set a short post-closing briefing schedule and both sides did briefs and replies, mostly on the definition of HCT/P’s. The reply briefs were submitted, per the judge’s order, on September 1st, as of which day the case was submitted and is now sub judice (legalese for pending decision by the court). One interesting note: Of course, the Government submitted to…

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The Private Stem Cell Field Moves On; Maybe This Time They’re Be Smarter or More Cautious

The Private Stem Cell Field Moves On; Maybe This Time They’re Be Smarter or More Cautious

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With the recent Summary Judgment decision in the US Stem Cell case, my prediction is that the fat-based stem cell business will slow down and eventually cease to be a thing. Here is the judge’s decision http://rickjaffeesq.com/wp-content/uploads/2019/06/USRM-lawsuit.pdf Lawyers will tell potential entrants into the field that a federal judge has held the use of autologous fat-based products to be illegal, at least pending and barring a different result in the FDA’s companion case in California. However, I do not think…

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