FDA

Guide to September 12-13 FDA Stem Cell Meeting

Stembucks, stem cell cartoon

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have …

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More tough FDA draft guidance on stem cells…still no action

FDA

The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally …

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FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet?

Stembucks, stem cell cartoon

Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of …

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FDA Draft Guidance Views Fat Stem Cells As Drugs

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With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem …

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What is the FDA’s appropriate role in regulating medical innovations such as stem cells?

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We need medical innovations, but what is the appropriate way for agencies like the FDA to regulate the process and fight bogus interventions based solely on hype? Without innovation, medicine becomes stagnant and hope fades for patients who have any one of numerous conditions that are currently inadequately addressed by medicine. I can relate on …

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Court in Regenerative Sciences Case: Propagated Stem Cells Are Drugs

A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and …

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Law and Order SVF: what is stromal vascular fraction?

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A big, fat elephant in “the room” of the commercial stem cell field today is something called stromal vascular fraction or SVF, made from human fat tissue or adipose. If you care at all about stem cells or the stem cell field more generally, you had better educate yourself on SVF. You can learn a …

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