FDA

Now is the Time to Stop Three-Parent IVF

The UK rubber stamp Embryo Authority has approved the manufacture of three-parent human embryos. The process is done by removing the nucleus from the egg of one woman, putting it into the enucleated egg of another, and then fertilizing with sperm. Voila, three biological parents. The approach is supposed to enable women with mitochondrial disease—who […]

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Adult Stem Cell Clinic Moves to Mexico

I am a huge supporter of adult stem cell research. But it needs to be done in the right way. Moreover, research subjects should never be charged for their own experiments as part of a for profit business — which, unfortunately, Texas permits legally — but that is not binding on the FDA. Now, an […]

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Stem Cell Treatments Are Drugs

I think this is the right decision. A federal judge has ruled that stem cell treatments that manipulate the cells into another form are drugs for purposes of FDA oversight. From the New Scientist story: It’s official: stem cells are drugs. At least, that’s the opinion of the US district court in Washington DC, which […]

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Texas Should Not Let Doctors Charge for Adult Stem Cell Research

By Wesley J. Smith, J.D., Special Consultant to the CBC I oppose off-label prescribing. I oppose states legalizing medical marijuana when it should be done by changing the Controlled Substances Act. I oppose novel interventions upon the disabled, such as “Ashley’s Treatment,” without proper regulatory studies and approval. I would certainly oppose a state allowing […]

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A Scientific Renaissance

Rick Weiss has an interesting piece over here on how stem cell research as we know it is on the way out, and is heading for an extreme make-over. He rightly reminds his readers on how conservative the FDA has been in allowing any human clinical trials to move forward with embryonic stem cells. “At […]

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FDA Delays Clinical Trails of Embryonic Stem Cells

Hah! The FDA, in its great and infinite wisdom said “now wait a minute” to Geron Corporation. Here’s the scoop in its entirety. The Geron Corporation announced Wednesday that its plans to begin the first clinical trial using embryonic stem cells had been delayed by federal regulators. The company, based in Menlo Park, Calif., had […]

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Sorry for the travel hiatus. Great trip to London. More to come on that later, but for now catching up on some great things in my inbox over the last week. My friend sent me this from Bloomberg.com which is very interesting on the role the FDA has on approving clinical trials in humans using […]

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