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Cell Therapy News/Articles, page-14389

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    This may have been discussed on other threads, but particularly pertinent to MSB, so even worth repeating.

    Many of you will (hopefully) be aware a Californian judge ruled in favour of the defendant in a recent stem cell case and basically put the FDA on its backside ruling by essentially declaring stem cell treatments to be exempt from Food and Drug Administration regulations, basically declining to block the California Stem Cell Treatment Center from continuing to offer purported stem cell treatments to customers per the FDA case - the judge ruling that their treatments were exempt from FDA regulations, in part because they were tantamount to surgical procedures.

    https://www.latimes.com/business/story/2022-08-31/federal-judge-tosses-lawsuit-targeting-stem-cell-clinic

    MSB's old friend Dr Marks has been busy since and is now getting pushed from many sides of the industry, the latest the perinatal sector pushing the FDA for answers against the regulatory backdrop:

    https://www.prnewswire.com/news-releases/perinatal-stem-cell-society-calls-emergency-session-to-garner-industry-support-for-fda-301659391.html

    (the FDA will no doubt appeal the ruling, but right now Surgeons can theoretically legally offer some stem cell treatments under the umbrella of surgical procedures - obviously an off the shelf product would still technically fall under the FDA's remit)
 
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