Search Results for: warning letter

Your stem cell legal documents hub

Below are links to specific court documents and filings in stem cell-related legal proceedings. (I’ve also placed in parentheses links to my posts/analysis on these).  Enjoy, especially you lawyers and investors. It’s a work in progress so expect more cases and documents to appear. In fact, if you have suggested additions please add them (plus […]

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What was the strangest event for stem cells in 2012? Pick from top 5 in poll

Every year around this time I put my “best of” the year in stem cells including awards such as my Stem Cell Person of the Year Award. For example here are the 2011 awards. This year I’m also trying with difficult to decide on what was the craziest thing for stem cells that happened in

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Celltex response to FDA says transplants stopped: what are the other key points?

The Houston Chronicle has posted the response letter from Celltex to the FDA in regard to the FDA Warning Letter issued to Celltex. The Chronicle also has a piece up on the warning letter that is a great read here. My thoughts on the possible paths for Celltex moving forward can be found here. The

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As stem cell industry explodes, can a static FDA keep up?

There are legitimate arguments about the degree to which the FDA should regulate stem cell clinics and the point-of-care, for-profit stem cell industry. I’ve held debates about that on my blog with argument on both sides including a very valuable debate between Dr. Chris Centeno and Doug Sipp. However, increasingly it is looking like the

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Nordstrom hawking super expensive, non-FDA approved stem cell cosmetic drugs

What’s the deal with Nordstrom and stem cells? Are they going to rename themselves “Nordstem”? I grew up in Bellevue, WA, home of the Nordstrom’s family and of the Nordstrom department store chain. I believe the flagship store was just across Lake Washington in Seattle. I don’t like shopping as perhaps most guys feel, but

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L’Oreal Lancome gets hammered by FDA, why kid gloves for clinics?

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Stem cell cosmetics is an exploding area ranging from facial creams (e.g. from L’Oreal and its Lancome) to face lifts to boob jobs to baldness treatments (see two key posts here and here for background and great stories). The stem cell cosmetics field has not been held back by issues such as the fact that

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Poll indicates major pessimism on future of Texas stem cell clinic, Celltex

What does the future hold for the privately-held Texas stem cell clinic, Celltex, that had given Governor Perry a stem cell transplant? I put up a poll a few days ago asking this question and the results have been striking. By way of background, it’s been a complicated few weeks for Celltex. Almost a month ago, I

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