Search Results for: warning letter

L’Oreal Lancome gets hammered by FDA, why kid gloves for clinics?

Patricia-Pineau-300x2541

Stem cell cosmetics is an exploding area ranging from facial creams (e.g. from L’Oreal and its Lancome) to face lifts to boob jobs to baldness treatments (see two key posts here and here for background and great stories). The stem cell cosmetics field has not been held back by issues such as the fact that […]

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Poll indicates major pessimism on future of Texas stem cell clinic, Celltex

What does the future hold for the privately-held Texas stem cell clinic, Celltex, that had given Governor Perry a stem cell transplant? I put up a poll a few days ago asking this question and the results have been striking. By way of background, it’s been a complicated few weeks for Celltex. Almost a month ago, I

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ICMS President Rodriguez interview on adult stem cell regulatory issues

The International Cellular Medicine Society (ICMS) has emerged as an important organization related to stem cell regulatory issues. I think that many people do not understand what ICMS is all about and it certainly evokes strong opinions in the stem cell field. If you care about stem cells then you need to know about ICMS

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Stem cell grapevine: FBI readying to take more action against dubious clinics & docs

A rumor is now going around that some dubious stem cell docs and clinics are likely to get visits from the FBI soon! The FDA, which has just recently issued a couple warning letters (here and here), potentially together with the FBI, may be poised to take more decisive action in the near future in the next

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Have we crossed the tipping point to stem cell disaster?

Steven-Victor-250x3001

Earlier this year, Dr “LookGood” aka Dr. Steven Victor, cosmetic surgeon to the stars, received a warning letter from the FDA over how his clinic was handling stem cell-related procedures. The FDA listed 16 issues as problems. On April 20, Dr. Thomas E. Young of Young Medical Spa in Pennsylvania also received an FDA warning

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What you need to know about Martin Makary and planning for the Trump 2.0 FDA

Martin Makary, Trump FDA

How might Trump’s nominee to lead the FDA, Martin Makary, change the agency? Should we be worried or hopeful? I’ve been closely following the FDA and its commissioners ever since I started The Niche in 2010. I’ve been particularly interested in how these leaders impacted FDA actions on cell and gene therapies. How might Makaray

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Cell Surgical Network asks whole court to weigh in after FDA appeals victory on stem cells

Cell Surgical Network stem cell clinic chain

It’s been a long saga for the FDA and the unproven stem cell clinic group called Cell Surgical Network, headquartered in Beverly Hills. A court case involving the two has been unfolding for many years. It has big implications for agency authority and the hundreds of stem cell clinics across the U.S. The case took

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