As I first reported, the FDA conducted a two-week audit of Texas adult stem cell firm, Celltex, sometime in April. Today I received a copy of the so-called “483 report” of that audit. It is basically a summary of problematic issues that the FDA says need to addressed. The FDA report is cause for some […]
Surprising FDA audit report of Celltex a blow to dubious stem cell clinics Read More »
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 »
What does the FDA define as “minimally manipulated” when it comes to biologics such as stem cells? You will be shocked to find out, but they include irradiation and treatment with the super toxin/carcinogen, ethylene oxide. In a recent post I discussed the issue of an apparent “minimal manipulation” exception (some might even call it a
Are stem cells a drug? Should the FDA regulate them? Technically, the FDA calls stem cells “biologics”, but the FDA regulates stem cell products with the goal of ensuring safety and efficacy much the same as traditionally define chemical “drugs”. You can learn more about the FDA’s view of and concerns about stem cells here and here.
Are stem cells drugs? Read More »