Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance […]
FDA outlines potential crackdown on Clinicaltrials.gov offenders Read More »
Last year I started seeing stem cells mentioned along with the opioid crisis in a particular way, but now recently I saw an entirely different pairing of stem cells with the opioid crisis. The first connection I saw was of a few for-profit, unproven clinic firms claiming that for pain sufferers it would be better
The opioid crisis, pain, stem cells, & FDA Read More »
For me there was a sense of “finally” when just under 3 months ago the FDA filed suits via the DOJ against 2 stem cell clinic firms, U.S. Stem Cell (and its affiliate U.S. Stem Cell Clinic, collectively referred to here as USRM) and California Stem Cell Treatment Center/Cell Surgical Network (collectively referred to here as
As 2 FDA stem cell clinic suits slowly unfold, more action needed now Read More »
When you get an FDA warning letter (like if you are a non-compliant stem cell clinic) you generally aren’t feeling too well after reading it, but now there’s an extra thing to worry about according to the FDA. A fake FDA warning letter. Apparently 3-dozen or more of these fake FDA warning letters sparked complains
Fake FDA warning letter scam Read More »
I didn’t know until recently that the FDA has a blacklist, which is called the “FDA Debarment List”. You can check it out here. Should one or more particularly egregious unproven stem cell clinic operators should be on the list given their risk-taking with patients in the name of profit? There aren’t any on there
A real FDA blacklist: what is it, who’s on it, & should some stem cell clinics be? Read More »
The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally
10 questions on FDA suits targeting stem cell clinics Read More »
Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits?
When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon? Read More »
At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »
The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point
In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms Read More »
If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a
40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke Read More »