Search Results for: peter marks

Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks

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I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of …

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Striking FDA Hahn & Marks JAMA pub on regenerative clinics

Dr-Stephen-Hahn-Commissioner-of-FDA

It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other …

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Did COVID derail FDA stem cell clinic plan?

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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One size doesn’t fit all? FDA may soften some cell therapy regs

dr. peter marks fda, cell therapy

The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways …

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Grading my 21 stem cell & regenerative medicine predictions for 2021

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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

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

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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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Recommended reads: PSC, COVID, FDA pledge, sci jobs

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When you sit down to read science on the weekends lately, assuming you are not primarily a COVID-19 researcher, how much COVID stuff seeps into your reading? As I was going over some of this year’s recommended weekly reads posts here on The Niche, I’ve realized that an increasing amount of COVID-19 research has joined …

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Politics & FDA OK 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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