FDA Archives - Page 5 of 11

Scott Gottlieb leaving FDA: possible reasons, impact on stem cell field, & more

March 6, 2019 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out […]

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New Florida bill mixes RTT spirit with turning unproven stem cell sales into a felony

January 31, 2019 / Professor Paul Knoepfler, Ph.D.

A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process. What’s going on? A number of states have been stepping up action

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FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely

December 23, 2018 / Professor Paul Knoepfler, Ph.D. / 7 Comments

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a

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Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex

November 14, 2018 / Professor Paul Knoepfler, Ph.D. / 3 Comments

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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To report a sketchy stem cell clinic, a list of simple, concrete things to do

November 7, 2018 / Professor Paul Knoepfler, Ph.D. / 5 Comments

The stem cell clinic industry selling unapproved “therapies” is ubiquitous and yet somehow still growing it seems. Many of us are encountering more of them including via ads and the clinics are basically all over the place. What should someone do if they see a stem cell clinic that is particularly concerning? A lot of

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Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks

October 14, 2018 / Professor Paul Knoepfler, Ph.D.

I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of

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The opioid crisis, pain, stem cells, & FDA

August 12, 2018 / Professor Paul Knoepfler, Ph.D. / 8 Comments

Last year I started seeing stem cells mentioned along with the opioid crisis in a particular way, but now recently I saw an entirely different pairing of stem cells with the opioid crisis. The first connection I saw was of a few for-profit, unproven clinic firms claiming that for pain sufferers it would be better

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Attorney Jaffe, fan of less oversight, still clobbers Florida stem cell clinic firm

August 5, 2018 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Attorney Richard Jaffe, who has been an advocate for clinics to have the right to sell and patient to buy unproven therapies such as the stem cells sold by clinics and unproven cancer therapies, just did a kind of shocking u-turn on a specific point. Jaffe and I have very different philosophical views of the

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Fake FDA warning letter scam

July 22, 2018 / Professor Paul Knoepfler, Ph.D.

When you get an FDA warning letter (like if you are a non-compliant stem cell clinic) you generally aren’t feeling too well after reading it, but now there’s an extra thing to worry about according to the FDA. A fake FDA warning letter. Apparently 3-dozen or more of these fake FDA warning letters sparked complains

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A real FDA blacklist: what is it, who’s on it, & should some stem cell clinics be?

June 25, 2018 / Professor Paul Knoepfler, Ph.D. / 2 Comments

I didn’t know until recently that the FDA has a blacklist, which is called the “FDA Debarment List”. You can check it out here. Should one or more particularly egregious unproven stem cell clinic operators should be on the list given their risk-taking with patients in the name of profit? There aren’t any on there

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