Scott Gottlieb

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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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the …

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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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Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex

Stemgenex

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many …

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In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms

Kristin-Comella1

The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point …

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40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke

blowing-smoke-FDA-stem-cell-clinics

If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a …

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‘Very Alarmed’: North Dakota AG Investigating Stem Cell Clinic

West-2-North-Medical-Solutions-stem-cell-clinic

According to The Bismarck Tribune and the AP/US News & World Report, the North Dakota Attorney General’s office is investigating a stem cell clinic in that state amid complaints. From the news articles: “The clinic has been offering stem cell injections for about a week and a half. Consumer Protection Division Director Parrell Grossman says there are …

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Deconstructing FDA’s Mixed Bag Approach to Stem Cell Clinics

FDA-draft-guidance

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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Fat stem cells are drugs & more: FDA final guidances point to a new era

FDA-stem-cell-policy-flow-chart-e1510854295902

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …

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