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Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

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FDA

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest […]

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Bad Batch podcast’s dark picture of perinatal stem cell industry

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John Kosolcharoen, Liveyon

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have

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Bad Batch podcast is must listen for stem cell community

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Bad-Batch-Podcast

I’m relatively new to podcasts, but am enjoying a new stem cell-focused one called Bad Batch by medical journalist Laura Beil, which I’ve been listening to in the car as I commute. I just finished episode three. I’m curious to hear how the next few episodes of the story unfold. I talked and emailed with

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‘Bottom of stem cell barrel’? Utah piece sparks legal threat

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derek-lowe-e1564527793287

Up until now Utah hasn’t immediately come to mind as a hub for stem cell issues, but things are heating up there in 2019. Utah? I was going to do a blog post here on The Niche last month about perinatal (birth-related) biologics and stem cell-related supply companies in Utah. Some of their customers appear

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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

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R3-Stem-Cell-testimonials

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a

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Weekend reads include herding brains, stem cells, & CRISPR

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Stem-cells-the-niche-anti-aging

Every so often here on The Niche I list science and news articles worth a look as “weekend reads”. Below is my list for this weekend. Enjoy! The first article doesn’t really fit into the other main categories, but the title “herding brains” caught my eye. Stem Cells Stem cells and regenerative capacity in aging

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FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely

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Dr.-Scott-Gottlieb

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a

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