Search Results for: scott gottlieb

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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Clinic biz US Stem (USRM) may be kaput in matter of weeks or months

Joint-motion-for-summary-judgement-1

In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further, …

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50 stem cell influencers on Twitter to follow in 2019

stem cells on Twitter, top-stem-cell-influencers-Twitter

Who are the top stem cell and regenerative medicine influencers to follow on Twitter and elsewhere in 2019? Terrapin asked this kind of broad question to some within our community about 5 years ago and came up with a Top 50 list of stem cell influencers, which I like to joke I was “at the top …

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Stem cell clinic doc being sued by FDA now gets agency warning for unapproved breast device

Elliot-Lander-and-Mark-berman-300x2331

When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. …

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When the state & ‘rogue’ scientists collide: case of China & CRISPR baby guy He Jiankui (贺建奎)

He-Jiankui-贺建奎

What happens next to He Jiankui (贺建奎) or as some people now refer to him, the “CRISPR baby guy”? China has a challenging situation to resolve here, but such conflicts between scientists and governments have happened regularly in history. When scientists go “rogue” (i.e. don’t conform to norms or ethical standards in an extreme way or …

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Several new investigations expose ‘snake oil’ stem cell clinics

snake-oil-stem-cell-clinics

We need more investigations of for-profit stem cell clinics selling what some view as ‘snake oil.’ Over the years I’ve mainly resisted using terms like “snake oil,” but that phrase is being used more often and more recently I think we need to be blunt about what is being sold. Part of effectively countering the …

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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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My new Cell Stem Cell piece: too much carrot & not enough stick on stem cell oversight

carrot-and-sticks

I have a new Cell Stem Cell piece out today that aims to take stock of today’s stem cell regulatory oversight in the U.S., Japan, and elsewhere including Australia, Canada and India. I use a carrot and stick metaphor for encouraging legit research and taking regulatory action on serious non-compliant activities, respectively. Where is stem cell …

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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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