Search Results for: scott gottlieb

FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms

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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

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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

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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

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

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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)

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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

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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

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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

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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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