Did Celltex just get an FDA warning letter? I’m not sure. We may find out tomorrow as the FDA updates their public warning letter list early in the week. What’s Celltex? Celltex is that famous stem cell company in Sugarland, Texas that gave Guv Rick Perry stem cell transplants. It was inspected by the FDA …
If you ever had a really bad day, March 13, 2012 might have been just such a bad day for one Dr. Steven Victor, aka “Dr LookGood”, because he received an official warning letter from the FDA. Why? Dr. Victor, who reportedly greets each patient with the catch phrase “You look so much more beautiful than your picture”, is …
Dr Lookgood, dermatologist to the stars, gets FDA warning letter Read More »
The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past …
3rd Invitrx warning highlights FDA oversight weakness Read More »
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
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 …
FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms Read More »
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 …
Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters Read More »
When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. …
The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning …
FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem Read More »
What’s the deal with this week’s FDA Warning Letter to 23andMe? First some background. I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome. With this background, I decided some time ago to take the plunge and experience what …
23andMe and the FDA: Perspectives on Warning Letter Read More »
So many things go wrong during the lead up to clinically-evident Alzheimer’s disease. This complex disease pathway has, in turn, led to a vast array of approaches to try to treat or prevent Alzheimer’s. Most of these efforts one way or another have something to do with the amyloid plaques and tangles that accumulate in the …