Those who follow the stem cell field might be familiar with stem cell clinic operator Neil Riordan. According to a recent press release and some news reports, Riordan just had some bad news in court related to a stem cell clinic in the U.S. Stem cell clinic lawsuit As background, why do those running stem …
$7.8 million verdict in stem cell clinics case against Neil Riordan Read More »
The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a …
New data on stem cell clinics, INDs, & more including from FDA itself Read More »
Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics …
Even in COVID times the FDA continues its stepped-up efforts against stem cell clinics and patients are suing clinics more too, which I cover in today’s post along with recommended stem cell research pubs. One of the papers at the top of my to-read list is on 3D chromatin in stem cells. FDA Warning Letter …
It’s encouraging to see that the states including now Arkansas via their attorney generals (or is it attorneys general?) are taking more action against stem cell clinic firms, but the big scope of AG action has somewhat surprised me. Arkansas AG suit The latest AG action on a stem cell clinic type firm comes from …
Arkansas adds to wave of state AG actions vs. stem cell clinics Read More »
In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about …
FDA OK’s more COVID-19 efforts of unproven stem cell clinics 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 »
Texas Governor Greg Abbott has effectively banned abortions in his state during the COVID-19 pandemic, but his reasoning makes no sense and is inconsistent with his policies more generally on health-care clinics. The Tribune notes that while “Abbott’s original ban was intended to preserve medical resources”, his own statements contradict that, including “On Friday, he …
Texas Gov Abbott pandemic hypocrisy on abortion vs. stem cell clinics Read More »
It’s not every day that I call a bunch of stem cell clinics to say “hi”, but yesterday I called some of them during a needed lunch break from grant writing to see what they were doing about their operations during the COVID-19 pandemic. The impetus for this survey of a sort was a question …
A variety of states have stepped up to address unproven stem cell clinics within their borders and the latest is Vermont. According to the VTDigger and writer Anne Wallace Allen, the Vermont Medical Society is planning a number of steps to address this situation. For example, at their encouragement a Vermont lawmaker will introduce legislation …