REGROW Act stem cells

Wouldn’t you like to be a RAT too? Stem cell clinics apply for new FDA accelerated approval path

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Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some …

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REGROW Act 2.0 still no-go with big risks to patients & field

Mark-Kirk-REGROW-Act

The REGROW Act is a bill that seeks to lessen the regulatory burden to accelerate getting stem cells to patients more quickly, but it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole. The REGROW Act, which is sponsored by Senator Mark …

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Is REGROW Act anti-embryo research? Pluripotent stem cells excluded

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The REGROW Act has attracted both support and criticism, including on this blog, for the changes it would mandate in the way the FDA regulates stem cell products. More specifically it would greatly reduce regulation of experimental stem cell products. I believe that would be dangerous to patients and to the stem cell field more …

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Alliance for Regenerative Medicine (ARM) Opposes REGROW Act, Risks to Patients Cited

Alliance-for-Regenerative-Medicine

The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for …

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REGROW Act is Attack on Science-Based Stem Cell Trial Oversight

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Senators Mark Kirk, Joe Manchin, and Susan Collins have proposed new legislation in the form of the REGROW Act that would substantially interfere with the FDA’s ability to properly regulate the development of new stem cell and regenerative medicine therapies based on hard science. The REGROW Act would force the FDA to allow rushed introduction of experimental stem …

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