Search Results for: scott gottlieb

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

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

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

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

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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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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2020 The Screamers Science Hype Award goes to Stephen Hahn

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

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

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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Permanent injunction on clinic firm US Stem Cell is big blow to fat clinics

US-Stem-Cell-Clinic-2

Today the United States District Court of the Southern District of Florida entered a permanent injunction against stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmed by the unproven treatments sold by these firms. US Stem had lost the case a couple weeks back, but now …

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