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Tag: stem cell regulation

Stem Cell End of the Year Legal Update

Stem Cell End of the Year Legal Update

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As those in the field remember, in the fall of 2017,  with greatest of largesse, the FDA proclaimed that it would exercise its enforcement discretion and give all but the most egregious/dangerous private stem cell clinics three years to come into compliance with its view that autologous based stem cells, even if administered during the “same surgical procedure” were in violation of the FDA’s revised interpretation of its 21 CFR 1271 regulations. The FDA’s reimaged view of its power to…

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Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

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Now would be a good time for private stem cell clinics to change their web site advertising

Private stem cell clinics should start worrying about some new regulatory players

Private stem cell clinics should start worrying about some new regulatory players

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Up until very recently, the FDA has basically been the sole regulatory threat to the private/for-profit stem cell clinics, via published guidance documents, site inspections, warning letters and the recent federal civil injunction cases against the two biggest stem cell operations. See my posts about the status of these cases at: http://rickjaffeesq.com/2018/09/26/update-on-fda-injunction-cases/ As an aside It’s no coincidence that the defendants in both of these injunction cases have many dozens of so-called “affiliate” stem cell clinics throughout the country. Both…

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First 2018 Stem Cell Update

First 2018 Stem Cell Update

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We’re now beginning the second month of 2018, and we are a few months past the FDA’s issuance of the final stem cell guidance documents which are intended to dramatically limit the availability of stem cell treatments outside of FDA approved clinical trials. See my prior post at: http://wp.me/p7pwQD-bB So what’s going on so far in 2018? FDA Inspections? Rumor has it that there already have been several facility inspections this year. What I can say is that it’s more…

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I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

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I’ve just had the distinct but perhaps questionable honor of being quoted extensively by the Grand Inquisitor of all things unconventional (medicine wise). here is his post: https://respectfulinsolence.com/2017/11/21/fda-cracks-quack-stem-cell-clinics/ Like M.C. Escher so brilliantly explains in his pictures, it all depends on your perspective, whether you think the the FDA final guidance documents are a good or bad thing. But, one thing I’ve never been able to figure out about the other side is why the obsession with the stem cell…

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Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

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As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s. The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate. Based on recent FDA action against a couple of these clinics (see my prior post at http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/),the tea leaves weren’t looking good for the FDA loosening-up the rules in the final version. Well,…

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The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

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In late August, the FDA issued a trilogy of pubic actions and announcements advancing its goal of shutting down what I’ll call the practice of medicine stem cell clinics (“POM”). These clinics provide autologous stem cells and other autologous tissue or tissue based products which have not been approved by the FDA. These clinics have exploded in popularity over the past dozen years, which has caused the FDA and the stem cell institutional players much angst. The FDA’s efforts to…

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ALL’S MOSTLY QUIET ON THE FDA FRONT, but don’t expect that to last now that there’s a New FDA Commissioner

ALL’S MOSTLY QUIET ON THE FDA FRONT, but don’t expect that to last now that there’s a New FDA Commissioner

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It seems like forever ago since the FDA’s 2015-2016 attempt to increase its regulatory powers, or more pointedly, since the FDA regulatory thugs have tried to dramatically restrict the personal freedom of US citizens. The good news is that most of the major proposed changes are still up in the air. The not-so-good news is that now that the FDA has a new commissioner (Scott Gottleib was confirmed by the Senate on April, 27, 2017), I’m expecting things to happen,…

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Game Changing the Stem Cell Debate

Game Changing the Stem Cell Debate

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It’s been almost a month since the FDA’s two day hearing on the draft guidance documents on autologous stem cells. Here is the short version of what happened: The stem cell research industry, meaning the basic scientists and academic physicians employed at big institutions, and their acronym organizations like the draft guidances. They agree with the FDA that non-homologous, (roughly meaning therapeutic as opposed to replacement) autologous (i.e. my) stem cells (or any kind of autologous tissue or “HCT/P’s”) should…

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FDA Stem Cell Meetings Close at Hand: Stakeholders on Both Sides are Worried, but One Side Should be Really Worried.

FDA Stem Cell Meetings Close at Hand: Stakeholders on Both Sides are Worried, but One Side Should be Really Worried.

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Next Monday and Tuesday, September 12 and 13th is a widely acknowledged big day in the stem cell world; it’s the two day public hearing on the FDA’s four draft guidance documents.  (Here is a link to the FDA’s announcement. http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm.  The entire event will be live broadcast via a link on this FDA page. The draft guidances are a big deal because, as I’ve said before,  http://rickjaffeesq.com/2016/04/21/stemcells/,  they will make illegal almost all autologous cell transplants outside of FDA…

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