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

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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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Stem Cell Person of the Year 2014 Award: Vote To Choose 12 Finalists

Stem-Cell-Symbol

Nominations have closed and we have more than two dozen nominations for Stem Cell Person of the Year 2014. It’s an exciting, diverse group including some news faces as well as nominees from years past as well. Happy Stem Cell Day! You can now vote for your choice for the top finalists in the poll

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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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