Search Results for: stem cell clinics

Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

Robert Califf, FDA Commissioner

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I […]

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Weekly reads: brain aging, perinatal stem cell clinics, $1M lab meat fine bill

brain aging

What happens during brain aging and how can we tell if dementia is coming? Are there particular early hallmarks? There are an increasing number of medical tests for predicting or detecting dementia. Alzheimer’s disease can often be detected early. But what do patients or their doctors do with such information? Until recently there weren’t any

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Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics

AABB, FDA

The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,

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$7.8 million verdict in stem cell clinics case against Neil Riordan

RMI

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

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New data on stem cell clinics, INDs, & more including from FDA itself

arm slide fda trip program

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

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FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

stem cell clinics map

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

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Arkansas adds to wave of state AG actions vs. stem cell clinics

Sarah-Knife-Chief-M.D.-chiropractor-Serge-Francois-D.C.-From-KNWA-small

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

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FDA OK’s more COVID-19 efforts of unproven stem cell clinics

The-FDAs-big-COVID-stem-cell-clinic-can-of-worms-small

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

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FTC fires off many warnings to stem cell clinics on COVID-19

BioXcellerator-warned-by-FTC-over-stem-cells-for-COVID-19-has-many-promotional-videos.-This-is-a-screenshot-from-one.

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

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