The last six months I’ve been spending even more time than usual writing NIH grants (and a few others). The last two weeks have been especially busy on this front as I am getting an R01 renewal out the door. My paper reading lately has been mostly related to the grant writing I’m doing. Still, …
Weekly reads: NIH grants, side effect of darker hair, FDA warning, CRISPR Read More »
If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with …
Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs Read More »
What can a gecko possibly teach us about skin cancer? Read on. It’s fun when a week’s worth of science reading covers so much territory including COVID-19, geckos that get cancer, a research misconduct sleuth, an FDA letter, and more. Baltimore weighs in on COVID lab origin idea Caltech has a very interesting interview with …
Recommended reads: Bik, FDA letter, gecko cancer model, David Baltimore on COVID origin Read More »
A firm called Utah Cord Bank has been in the news related to stem cell clinics over the past year or two. Now they have received an FDA Warning Letter for a variety of manufacturing issues. Utah Cord Bank Background In terms of some brief backstory, Utah Cord Bank first popped up on my radar …
FDA warning to stem cell clinic supplier Utah Cord Bank Read More »
The FTC has sharply increased its oversight activities against stem cell and regenerative clinic firms. These new actions include quite a few warning letters. Here is the FTC database for COVID-19-related warning letters. Note that recently the FTC added a new, helpful option to view all of its warning letters here. It’s a good source …
FTC fires off many warnings to stem cell clinics on COVID-19 Read More »
What’s been going on in the stem cell and regenerative medicine field over the past week and what are some worthwhile things to read? Today’s post has recommended recent reads from the scientific literature and the media. I’ve also got our weekly stem cell/regenerative medicine quiz question and the answer to last week’s. You can …
Recommended reads: FDA warning, COVID updates, stem cell pubs Read More »
The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on …
Historic spring storm of FDA letters to stem cell clinic industry Read More »
The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest …
Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game? Read More »
Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. FDA and R3 Stem Cell While the FDA didn’t send R3 Stem Cell a formal warning …
When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. …