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 »
What does homologous use mean? Navigating the arena of clinical use of a biologic such as stem cells or differentiated cells made from stem cells can be challenging. There are many important issues including what defines “minimal manipulation” of biologics such as cells. One particular issue that is critically important and has drawn less attention …
Time to bone up on homologous use in the stem cell field Read More »
In response to a FOIA request, the FDA informed me that they are continuing to investigate Texas stem cell clinic, Celltex. The firm has been flying somewhat under the radar lately. They have not responded to multiple requests for comments on various issues. The FDA indicated to me that what they can release in terms …
IntelliCell (SVFC) is a stem cell company that does cosmetic stem cell procedures. They’ve had a number of challenges of late including an FDA warning letter about a year ago and apparent financial issues manifesting in lawsuits. Now the company itself, perhaps trying to get ahead of the news, issued a press release (PR) saying they …
Intellicell Inspected By FDA: What Does It Mean? Read More »
Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through …
My response to ‘Our Bodies, Our Cells’ Harvard post on deregulation Read More »
The FDA is faced with years of a static budget and a rapidly growing stem cell and cell therapy for-profit sector. It also faces criticisms (some that it has acknowledged are legit) from certain folks in the stem cell field. If you could change just one thing about the FDA in terms of its oversight …
What Would be Your #1 Top FDA Reform on Stem Cells? Take our poll Read More »
Stem cell cosmetics is an exploding area ranging from facial creams (e.g. from L’Oreal and its Lancome) to face lifts to boob jobs to baldness treatments (see two key posts here and here for background and great stories). The stem cell cosmetics field has not been held back by issues such as the fact that …
L’Oreal Lancome gets hammered by FDA, why kid gloves for clinics? Read More »
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 »