FDA Archives - Page 9 of 11

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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Full page JAMA ad from FDA warns docs on foreign drugs

November 7, 2013 / Professor Paul Knoepfler, Ph.D. / 10 Comments

I opened the most recent edition of Journal of the American Medical Association (JAMA) and found a striking full-page ad from the FDA. It’s unclear if this is the first ever such advertisement. I have been unable to find a similar one on the Internet at least. Has anyone seen such ads before? The JAMA

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USA v Regenerative Sciences Word Clouds are Illuminating

October 18, 2013 / Professor Paul Knoepfler, Ph.D. / 14 Comments

What can clouds tell us about a stem cell legal court case strategy such as USA v. Regenerative Sciences? It turns out, quite a lot. In about a week a Federal Appeals Court Case will begin to review the ruling in the USA v Regenerative Sciences that favored the FDA. This is arguably one of

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New FDA IntelliCell BioSciences, Audit Report: A Lot of Work to Do

August 9, 2013 / Professor Paul Knoepfler, Ph.D. / 2 Comments

IntelliCell BioSciences, Inc. of New York, a clinical stem cell establishment, has had a rough time of it lately. For example, a recent piece of bad news is that there is an impending foreclosure sale of the company’s assets. What exactly that means for the company more broadly remains unknown, but a few people tell me (take this

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Time to bone up on homologous use in the stem cell field

July 18, 2013 / Professor Paul Knoepfler, Ph.D. / 17 Comments

What does homologous use mean? Navigating the arena of clinical use of a biologic such as stem cells or differentiated cells made from stem cells can be challenging. There are many important issues including what defines “minimal manipulation” of biologics such as cells. One particular issue that is critically important and has drawn less attention

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Celltex letters to the FDA revealed by FOIA: first is reaction to Leigh Turner

July 9, 2013 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Celltex is still in the mix with the FDA and who knows how that will turn out. Several documents were revealed via FOIA that provide insight into the goings on at Celltex since 2012. Two documents are letters from Celltex to the FDA dated April 27, 2012 and May 18, 2012, while a third is a

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