FDA

Turner pub charts runaway stem cell clinic industry; FDA needs to think big now

U.S. Stem cell clinics map 2021.

Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging. He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016. I’m very glad that Leigh has continued this line of …

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Weekly reads: New FDA guidance, brains, MSCs, senescence

human mouse marmoset brain

This week marked the release of new draft FDA guidance on cell and gene therapies. Is the FDA kind of like the guidance counselor at school or more like the principal? It probably depends on many factors. I also find it funny how pretty much everyone in academia and biotech industry works to be compliant …

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Weekly recommended reads including asymmetric division & chromatin

Asymmetric division and chromatin

One of my favorite types of papers are those on stem cells and chromatin, and a new one in Current Biology caught my eye this week. My own lab website has the URL chromatin.com so that says something. You can also read more about our research here. Recommended reads: chromatin and stem cells, more Asymmetric …

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Translating the FDA’s Q&A on end of stem cell grace period

The Rosetta Stone, The FDA

The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers …

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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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Recommended reads: jobs, FDA letter, & The Niche new look

the body building fda letter the niche

During the week as I’m doing other stuff I keep my eyes open for interesting things to read, including over the weekend about stem cell research, COVID, CRISPR, and more for The Niche weekly recommended reads. This week a lot was going as we updated The Niche site to our new theme and format. I …

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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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Politics & FDA clearance of 2 stem cell clinic COVID-19 efforts

Anand-Srivastava

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of …

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