FDA

Full page JAMA ad from FDA warns docs on foreign drugs

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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

Regen-Sci-Cloud

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

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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FDA still investigating clinic firm Celltex

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In response to a FOIA request, the FDA informed me that they are continuing to investigate Texas stem cell clinic, Celltex. The firm has been flying somewhat under the radar lately. They have not responded to multiple requests for comments on various issues. The FDA indicated to me that what they can release in terms …

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Intellicell Inspected By FDA: What Does It Mean?

IntelliCell (SVFC) is a stem cell company that does cosmetic stem cell procedures. They’ve had a number of challenges of late including an FDA warning letter about a year ago and apparent financial issues manifesting in lawsuits. Now the company itself, perhaps trying to get ahead of the news, issued a press release (PR) saying they …

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My response to ‘Our Bodies, Our Cells’ Harvard post on deregulation

Mary-Ann-Chirba

Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through …

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What Would be Your #1 Top FDA Reform on Stem Cells? Take our poll

FDA

The FDA is faced with years of a static budget and a rapidly growing stem cell and cell therapy for-profit sector. It also faces criticisms (some that it has acknowledged are legit) from certain folks in the stem cell field. If you could change just one thing about the FDA in terms of its oversight …

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L’Oreal Lancome gets hammered by FDA, why kid gloves for clinics?

Patricia-Pineau-300x2541

Stem cell cosmetics is an exploding area ranging from facial creams (e.g. from L’Oreal and its Lancome) to face lifts to boob jobs to baldness treatments (see two key posts here and here for background and great stories). The stem cell cosmetics field has not been held back by issues such as the fact that …

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Celltex unsure if FDA agrees product isn’t a drug, but expects 2nd FDA visit soon

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I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below: Dear Dr. Knoepfler, Thank you for your interest …

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WSJ editorial on issue of stem cells as drugs misses the boat

Dr.-Scott-Gottlieb

Today there is an editorial piece in the WSJ about the recent court ruling giving the FDA authority to regulate stem cells grown in culture as drugs. As a stem cell scientist, I read this opinion piece with interest. Unfortunately it is behind a paywall, but I have outlined and discussed the key issues below. …

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