Search Results for: peter marks

Take-homes from new FDA NEJM stem cell piece including surprises

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FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some …

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FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem

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The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning …

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Mesoblast gets FDA RMAT; List of 10 total designations so far

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Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting …

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US Stem Cell bid for FDA RMAT rejected?

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Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The …

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Mapping & driving the stem cell ecosystem: key points of my new paper

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When you think of an ecosystem, do you imagine something like a forest or jungle full of different organisms? I usually do, but over the last few years I’ve also been thinking about this concept in a different way. I’ve been viewing the broad stem cell arena as an ecosystem. In that spirit, I’ve recently …

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Samantha Yammine: Multiple filters for stem cell research at Canadian stem cell conference

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By Samantha Yammine, PhD Candidate in Derek van der Kooy’s lab at the University of Toronto. See tweets live from #TMM2016 via @SamanthaZY here. Last week, 430 Canadian scientists, trainees, industry professionals, science communicators and international guests gathered in the picturesque ski town of Whistler, British Columbia for the annual Till & McCulloch meeting (TMM). …

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Wait, there’s an FDA stem cell meeting this week too? The scoop

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There’s a big FDA stem cell meeting coming along next week that has gotten much attention, but many people didn’t realize there’s also an FDA meeting on stem cells this week too in three days on September 8th. I pasted this week’s meeting schedule at the bottom of this post from the FDA page. The meeting is …

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