REGROW ACT

Perspectives on Cures Act stem cell provisions possible benefits & risks

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The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field.  What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the …

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Trump Has FDA in Crosshairs: Impact on Stem Cell Oversight?

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Will Trump trump the FDA? Our President-elect recently released his health care policy agenda and it looks like the FDA is a target in terms of reducing oversight. Over at the Washington Post, Carolyn Johnson has a nice article on this development. One point in the agenda in particular has caught people’s attention as potentially the key …

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Blogging today’s FDA stem cell meeting: Part 1

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The FDA is holding its first 2016 stem cell meeting today. How’s the meeting going? The meeting start awfully early for us West Coast folks (5:30am) so I didn’t get to see the first few talks. Did anyone else see those and if so, what was your impression? From the talks I have seen, this meeting …

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

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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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The backstory on my opinion piece in SF Chronicle critical of CIRM lobbying

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Today an opinion piece that I wrote about CIRM was published in the San Francisco Chronicle. The unusual element here is that the article is critical of CIRM. More specifically I raised concerns about a recent political trend at CIRM under its new President Randy Mills lobbying for dramatically weaker stem cell regulatory oversight. The Chronicle piece was first posted …

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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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