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 »
An FDA committee began a meeting yesterday that continues today to consider permitting new assisted reproduction-based “3-parent” technology that could address mitochondrial disorders, a serious human health problem. The technology also raises complex health issues of its own and invokes ethical questions. The goal of the FDA meeting is articulated this way: “the committee will
Why the FDA should not green-light 3-parent reproduction 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 »
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 »
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 »
Today I am posting Part 2 of my interview with Drs. Lander and Berman of the Cell Surgical Network. You can read Part 1 here, which is an interesting look inside the Network. The final portion of this blog post series, Part 3, is my take on their answers and you might not be surprised that
Cell Surgical Network Interview Part 2: SVF, FDA, & Homologous Use 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 »
Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has
Osiris FDA Letter: Trick or Treat? Read More »
ABC News just reported that the FDA is allgedly “cracking down” on the publicly traded company, MiMedx (MDXG), which sells a placental derivative touted for healing powers. The Wall Street Journal is also following the story. According to ABC News: MiMedx is a publically traded, for-profit company that takes donated human placentas — solicited via a website featuring
MiMedx (MDXG) placental “stem cell magnet” drugs attract FDA attention and lawsuit Read More »
IntelliCell BioSciences, Inc. of New York, a clinical stem cell establishment, has had a rough time of it lately. For example, a recent piece of bad news is that there is an impending foreclosure sale of the company’s assets. What exactly that means for the company more broadly remains unknown, but a few people tell me (take this
New FDA IntelliCell BioSciences, Audit Report: A Lot of Work to Do Read More »