With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem […]
FDA Draft Guidance Views Fat Stem Cells As Drugs Read More »
It’s been a seemingly rather quiet year on the FDA regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank
FDA on Key Stem Cell Regulatory Issues & Its Own Research Read More »
What the heck happened to the FDA when it comes to regulating stem cell clinics? Has it given up? Or does it just seem that way because it moves in slow motion? The FDA might as well have thrown in the towel because, as I like to say, the stem cell field moves in dog years.
Has the FDA given up on regulating stem cell clinics? Read More »
We need medical innovations, but what is the appropriate way for agencies like the FDA to regulate the process and fight bogus interventions based solely on hype? Without innovation, medicine becomes stagnant and hope fades for patients who have any one of numerous conditions that are currently inadequately addressed by medicine. I can relate on
What is the FDA’s appropriate role in regulating medical innovations such as stem cells? Read More »
A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and
Court in Regenerative Sciences Case: Propagated Stem Cells Are Drugs Read More »
How is the FDA doing on regulating stem cell treatments in the US and what should it do looking to the future? Please take the 4 polls below to indicate your thoughts and also add comments to tell us more about your thinking on these key questions.
4 New Polls on FDA Regulation of Stem Cells Read More »
A big, fat elephant in “the room” of the commercial stem cell field today is something called stromal vascular fraction or SVF, made from human fat tissue or adipose. If you care at all about stem cells or the stem cell field more generally, you had better educate yourself on SVF. You can learn a
Law and Order SVF: what is stromal vascular fraction? 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 »
I opened the most recent edition of Journal of the American Medical Association (JAMA) and found a striking full-page ad from the FDA. It’s unclear if this is the first ever such advertisement. I have been unable to find a similar one on the Internet at least. Has anyone seen such ads before? The JAMA
Full page JAMA ad from FDA warns docs on foreign drugs Read More »
What can clouds tell us about a stem cell legal court case strategy such as USA v. Regenerative Sciences? It turns out, quite a lot. In about a week a Federal Appeals Court Case will begin to review the ruling in the USA v Regenerative Sciences that favored the FDA. This is arguably one of
USA v Regenerative Sciences Word Clouds are Illuminating Read More »