Search Results for: fda

Why did clinic supplier Liveyon halt sales but others kept going despite FDA?

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Liveyon-reincarnated

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in […]

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FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms

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Roya-Panah-Kosolcharoen

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day

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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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R3 Stem Cell still raises red flags for me after FDA letter including do one-get one meeting

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R3-Stem-Cell-Course

Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. FDA and R3 Stem Cell While the FDA didn’t send R3 Stem Cell a formal warning

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FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

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Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm

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FDA warns another perinatal stem cell supplier Stemell

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Stemell-logo

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain

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Congress pushes FDA on stem cell clinic mess in new letter

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Congress-letter-to-FDA-stem-cell-clinics-2019

It can be kind of a big deal when politicians, especially at the federal level, write the FDA about stem cells. Is this going to be good news or bad? Some combination? I tend to worry that some senators or representatives might pressure the FDA to weaken oversight. However, lately it seems like the opposite

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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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Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry

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Liveyon

The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that  in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow

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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

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umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the

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