Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning …
‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter Read More »
The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people …
FDA needs to act boldly on unproven exosome therapies Read More »
In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a …
Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in …
Why did clinic supplier Liveyon halt sales but others kept going despite FDA? Read More »
Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day …
FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms 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 …
This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm …
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »
As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain …
FDA warns another perinatal stem cell supplier Stemell Read More »
It can be kind of a big deal when politicians, especially at the federal level, write the FDA about stem cells. Is this going to be good news or bad? Some combination? I tend to worry that some senators or representatives might pressure the FDA to weaken oversight. However, lately it seems like the opposite …
Congress pushes FDA on stem cell clinic mess in new letter Read More »