Search Results for: USA v. Regenerative Sciences

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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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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Stem cell clinics, FDA, & giant, unapproved for-profit human experiments

Stem-cell-facelift-comic-e1452454386279

When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the …

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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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Your stem cell legal documents hub

Below are links to specific court documents and filings in stem cell-related legal proceedings. (I’ve also placed in parentheses links to my posts/analysis on these).  Enjoy, especially you lawyers and investors. It’s a work in progress so expect more cases and documents to appear. In fact, if you have suggested additions please add them (plus …

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