Recent content by gh253

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    CSN litigates regulatory status of culture-expanded stem cells starts on page 18. doesn't seem like a super strong argument to me but what do I know.
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    The FDA's Stem Cell Reformation Must Go Beyond COVID-19

    Insurers have a right to decide for themselves whether to cover stem cell therapy. It is not an issue to be decided by lobbying and legislation. Each individual has a right to have the freedom to access his own stem cells, but NOT the right to force others to pay for his treatment, and those who...
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    The FDA's Stem Cell Reformation Must Go Beyond COVID-19

    I had to unfollow A. Rahman Ford. He's so naive I find it irritating. Regulators are badly intentioned and have only relaxed the rules for COVID treatments because the issue has reached mass public attention and the political impetus is to find treatments, not block them. But for everything...
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    I emailed him yesterday and haven't heard anything back yet. Do you know if the court granted the FDA deference in the Regenerative Sciences case?
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    Dr. Centeno blogged that the "Kisor" case may open the door for CSN to argue that the FDA changed 21 CFR 1271.15(b) illegally. I don't know anything about the legal side of this, but would this present an opportunity for a patient or patient group to sue the FDA? Do you know where to find a...
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    Reconsidering speaking at the upcoming FDA hearing

    I'm scheduled to speak at the upcoming FDA hearing, but now leaning against doing so because I really strongly believe that it's a lost cause and that the agency is holding this charade with the full intention to curtail what's left of cell therapy in the U.S. FDA bureaucrats are the lowest form...
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    What's the regulatory situation in Japan?

    I keep reading that Japan has already adopted a law similar to what REGROW proposes; when was it passed and what are the details? Has it yet resulted in any products getting on the fast track for approval in Japan?
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    How much did Obama's election in 2008 have to do with the course of things?

    If Obama had not been elected in 2008 and appointed Hamburg, would cultured cells be regulated as drugs today?
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    What is the REGROW Act and how will it help patients?

    I've been reading about the so-called REGROW Act and so far haven't been able to find out any concrete details about how it might speed patient access to cell-based therapies sooner. Paul Knoepfler is hysterically opposed to it, so that it a promising sign. Anyone know the actual details?
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    Anyone know what this product is?

    Not that I will benefit from this or even want it, I'm just interested to read about it: "The first mass produced stem cell drug in the US will finally get approval from the FDA after almost two decades in the making." Anyone know...
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    What the Hell is this?

    Centeno tweeted this... FDA public hearing registration deadline is January 8th Interventional Orthopedics Foundation (IOF) and AACT requests that you register for this critical meeting. An important pending regulation...
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    The FDA is protecting the pubilc...from a cure for the leading cause of disability!

    This isn't actually about stem cells, but I think it's relevant enough to post here. For people like me with osteoarthritis, a renowned bioengineer by the name of Dr. Kyriacos Athanasiou, Chairman of the Department of Bioengineering at UC Davis, has developed the technology to biologically...
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    32 yo with whole-body osteoarthritis

    My name is Brian. As 32, I am afflicted with early-stage degenerative arthritis in nearly every synovial joint in my body. My condition is not genetic or congenital; I acquired it nine years ago as a result of a specific cause that I’m certain of. While still in its early stages and only mildly...