FDA Archives - Page 3 of 11

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

November 10, 2021 / Professor Paul Knoepfler, Ph.D. / 9 Comments

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

October 10, 2021 / Professor Paul Knoepfler, Ph.D. / 1 Comment

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

August 1, 2021 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

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

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

July 22, 2021 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

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

April 27, 2021 / Professor Paul Knoepfler, Ph.D. / 4 Comments

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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List of FDA Approved Cell and Gene Therapies

March 12, 2021 / Professor Paul Knoepfler, Ph.D. / 37 Comments

What are the current FDA Approved Cell and Gene Therapies? In the past many of us have wished there was a list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me, but I couldn’t find a list. As a result, I made a comprehensive list of FDA Approved Cell and Gene Therapies,

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

September 30, 2020 / Professor Paul Knoepfler, Ph.D. / 11 Comments

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

August 24, 2020 / Professor Paul Knoepfler, Ph.D. / 5 Comments

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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Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy

July 26, 2020 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Ready for the latest recommended weekly reads in the world of stem cells and the regenerative medicine space including a bunch of important new FDA posts & changes? This post has quite a lot on the FDA since it had a very big week with several new items of major importance to the cellular and regenerative

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