FDA Archives - Page 8 of 10

ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation

March 4, 2015 / Professor Paul Knoepfler, Ph.D.

In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has […]

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

January 5, 2015 / Professor Paul Knoepfler, Ph.D. / 28 Comments

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FDA Draft Guidance Views Fat Stem Cells As Drugs

December 22, 2014 / Professor Paul Knoepfler, Ph.D. / 30 Comments

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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FDA on Key Stem Cell Regulatory Issues & Its Own Research

December 1, 2014 / Professor Paul Knoepfler, Ph.D. / 2 Comments

It’s been a seemingly rather quiet year on the FDA regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank

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Has the FDA given up on regulating stem cell clinics?

August 8, 2014 / Professor Paul Knoepfler, Ph.D. / 14 Comments

What the heck happened to the FDA when it comes to regulating stem cell clinics? Has it given up? Or does it just seem that way because it moves in slow motion? The FDA might as well have thrown in the towel because, as I like to say, the stem cell field moves in dog years.

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

February 24, 2014 / Professor Paul Knoepfler, Ph.D. / 4 Comments

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

February 4, 2014 / Professor Paul Knoepfler, Ph.D. / 7 Comments

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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4 New Polls on FDA Regulation of Stem Cells

January 15, 2014 / Professor Paul Knoepfler, Ph.D. / 4 Comments

How is the FDA doing on regulating stem cell treatments in the US and what should it do looking to the future? Please take the 4 polls below to indicate your thoughts and also add comments to tell us more about your thinking on these key questions.

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Law and Order SVF: what is stromal vascular fraction?

December 2, 2013 / Professor Paul Knoepfler, Ph.D. / 3 Comments

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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23andMe and the FDA: Perspectives on Warning Letter

November 27, 2013 / Professor Paul Knoepfler, Ph.D. / 5 Comments

What’s the deal with this week’s FDA Warning Letter to 23andMe? First some background. I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome. With this background, I decided some time ago to take the plunge and experience what

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