Stem Cells FDA

Good final grades on my 20 x 2018 stem cell predictions

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Each year I make a list of stem cell predictions for the following year and I’ll release my predictions for 2019 soon, but first I’m grading how my 20 predictions for 2018 turned out. It seems I did better than usual predicting what would happen this year. I only got a couple partial credit or …

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Upside down, sometimes wacky fine print on stem cell clinic sites

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Scrolling through a stem cell clinic website can be a surreal experience. Going from the top of the page to the bottom can leave one feeling turned upside down. I wonder what the FTC thinks when they see these sites? Usually at the top of the webpage for many unproven stem cell clinics are big …

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Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women

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Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months …

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Polls: What will stem cell clinics & FDA do now?

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Now that in the past few months the FDA has issued stern statements (one this summer and more recently), both final and draft guidances, and at least one warning letter, what comes next?  What will the clinics do if anything moving forward? What if anything will the FDA do in terms of actual concrete actions? …

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Deconstructing FDA’s Mixed Bag Approach to Stem Cell Clinics

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In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to …

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Reactions to California’s new stem cell law on non-FDA approved clinic offerings

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What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds? You probably already know that I am supportive of the …

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Scientist’s dilemma: find a public voice on big issues or stay silent?

Scientists-Dilemma

There is a scientist’s dilemma: should you speak out on important, sometimes controversial issues in science, where you not only can potentially have positive impact, but also risk being attacked for it? Or do you remain silent? I’ve now been blogging for more than 7 years. I’ve battled the often exploitive for-profit stem cell clinics …

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

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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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