I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below: Dear Dr. Knoepfler, Thank you for your interest […]
Celltex unsure if FDA agrees product isn’t a drug, but expects 2nd FDA visit soon Read More »
Today there is an editorial piece in the WSJ about the recent court ruling giving the FDA authority to regulate stem cells grown in culture as drugs. As a stem cell scientist, I read this opinion piece with interest. Unfortunately it is behind a paywall, but I have outlined and discussed the key issues below.
WSJ editorial on issue of stem cells as drugs misses the boat Read More »
Stem cells grown in culture are drugs. Agree or disagree? I believe it is a correct statement. I don’t think it is even a question any more as it was a few months ago. Yes, I am convinced that the FDA, as supported by a recent federal court ruling, has it right that growing stem
2 decades as cell biologist tell me grown stem cells are drugs Read More »
Are stem cells drugs? At least for today, a federal court unambiguously ruled that the answer to this question for manipulated stem cells is “Yes”. The story has been reported in the media at New Scientist and Scope Blog. You can read over the key issues here. The court ruled in favor of the federal government and FDA and against
Court empowers FDA to regulate stem cells as drugs Read More »
A major scandal has erupted further regarding FDA monitoring of its scientists’ emails as reported by the NY Times. The FDA spied on the emails of its own scientists and other scientists. Some of the emails also involved correspondence with Congress and even the White House. Regardless of one’s position on what the FDA did,
Celltex is that adult stem cell company that treated Governor Perry and upwards of 80 other people with stem cell products that they grew in their lab in Texas. I wonder what the leadership of Celltex is thinking right now about its FDA audit, their future, and that pesky professor/blogger in California…what’s his name? I
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 »