Search Results for: gottlieb

Scott Gottlieb leaving FDA: possible reasons, impact on stem cell field, & more

February 1, 2021 / By / 3 Comments
Dr.-Scott-Gottlieb

Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out …

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FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely

June 8, 2022 / By / 7 Comments
Dr.-Scott-Gottlieb

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a …

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Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine

February 1, 2021 / By / 3 Comments
Dr.-Scott-Gottlieb

New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in …

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How Scott Gottlieb may transform the FDA’s approach to stem cells

February 1, 2021 / By / 2 Comments
Dr.-Scott-Gottlieb

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to  the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such …

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Did COVID derail FDA stem cell clinic plan?

June 29, 2022 / By / 2 Comments
Mark Raza FDA stem cell clinic plan

The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven …

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Grading my 21 stem cell & regenerative medicine predictions for 2021

June 7, 2022 / By / 3 Comments
stem-cell-crystal-ball-300x3001

The world of stem cell research and regenerative medicine is unpredictable but it’s fun to be a part of it and try to do predictions. Each year in late December or early January I make prognostications for the coming year for stem cell research and regenerative medicine. I made 21 such predictions for the current …

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

April 27, 2021 / By / 4 Comments
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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2020 The Screamers Science Hype Award goes to Stephen Hahn

June 8, 2022 / By / 2 Comments
Dr-Stephen-Hahn-Commissioner-of-FDA

Today’s post announces the winner of the 2020 The Screamers Science Hype Award. Since this is the inaugural year for The Screamers, I’m just going to give out one main award: Overall Worst Science Hype. Science Hype Award to FDA Commissioner Stephen Hahn Remarkably, the winner of the overall The Screamers Award for Science Hype …

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21 Stem Cell Research & Regenerative Medicine 2021 Predictions

February 1, 2021 / By / 6 Comments
stem-cell-crystal-ball-300x3001

In any given field of biomedical science like stem cell research and regenerative medicine, it’s very useful if you can accurately predict the future. It seems, though, that predictions are far more difficult within the more exciting and rapidly-changing fields. The field of stem cells and regenerative medicine fits that bill. Past stem cell research …

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FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms

September 26, 2023 / By / 13 Comments
Roya-Panah-Kosolcharoen

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day …

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