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 […]
Nordstrom hawking super expensive, non-FDA approved stem cell cosmetic drugs 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 »
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 »
This post is focused on the important facts you need to know about stem cells as drugs and stem cell treatments. Many of the folks out there who want to earn a living to scamming vulnerable patients with so-called “stem cell treatments” have been upset that the U.S. FDA continues to view stem cell-based therapies
Stem cell treatments, drugs, and the key facts you need to know Read More »
What are the most significant stem cell and regenerative medicine good news stories of 2024? Since it has been an eventful year, there are many possibilities. Please see our poll at the bottom of this post and weigh in on what you think is the most important encouraging news. If you don’t see your choice
Poll on stem cell & regenerative medicine good news of 2024 Read More »
Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,
Remember cryonics, the idea that you could hit pause on human life? This relies on the super-cold power of liquid nitrogen or some other ultra-freezing method. Apparently cryonics is still a thing and there are people with even just their heads frozen. A new story claims a different way to hit the pause button on
Weekly reads: hit pause on human life, CIRM pause, 23andMe data, blast from the past Read More »
This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve
Big spike in FDA warning letters to unproven biologics firms Read More »