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FDA untitled letter

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

November 25, 2019 Paul Knoepfler 9

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, […]

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Prof @UCDAVIS Stem cells & Kids Brain Cancer Epigenomics #CRISPR Science policy/ethics. #scicomm TED https://t.co/4XhF0V5XiZ New book on making dragons🐲https://t.co/q9ezUzZdtx

Paul Knoepfler
pknoepflerPaul Knoepfler@pknoepfler·
7h

Wow, Liveyon has stopped sales of unproven umbilical cord cells after FDA warning letter
@lauriemcginley2
https://washingtonpost.com/health/2019/12/13/california-stem-cell-company-halts-sales-after-fda-warning/ Here's my take on that warning letter & other recent FDA steps https://ipscell.com/2019/12/fda-spike-clinic-supplier-liveyon-warning-letter-notice-on-exosome-harms/ I bet @BadBatchWondery podcast also played a role #stemcells

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pknoepflerPaul Knoepfler@pknoepfler·
7h

Bizarro cartoons often have me thinking of sketchy stem cell clinics, when they really having nothing to do with that. #stemcells Have Friday #TGIF

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james_jamstewJames Stewart@james_jamstew·
13 Dec

FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms https://ipscell.com/2019/12/fda-spike-clinic-supplier-liveyon-warning-letter-notice-on-exosome-harms/ via @pknoepfler

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