#regrow act

[gorskon]

The 21st Century Cures Act passes, turning the FDA into a puppet of the pharmaceutical industry

The 21st Century Cures Act passes, turning the FDA into a puppet of the pharmaceutical industry

Well, it’s done. Today, the Senate passed the 21st Century Cures Act, a bill designed to weaken the FDA and empower pharmaceutical companies, sending it to President Obama’s desk. There’s no way Obama won’t sign it, as it contains provisions funding his Precision Medicine Initiative, and he supported it all along. For all its flaws, I knew the bill’s passage was inevitable since after the…

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[pknoepfl]

Perspectives on Cures Act stem cell provisions possible benefits & risks

Perspectives on Cures Act stem cell provisions possible benefits & risks

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 stem cell provisions in Cures. What would it mean? Cures’…

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[pknoepfl]

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

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

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 indicator of what is to come for regulatory oversight of…

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[pknoepfl]

REGROW Act to do reappearing act?

REGROW Act to do reappearing act?

One of the biggest stem cell news stories of 2016 has been the REGROW Act, a bill intended to accelerate investigational stem cell and regenerative medicine therapies to patients by lessening FDA oversight, but in the last couple months REGROW has mostly disappeared from the news.

Will REGROW do a reappearing act like some kind of magician?

REGROW is in fact still out there so it is not gone by…

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[pknoepfl]

Blogging today's FDA stem cell meeting: Part 1

Blogging today’s FDA stem cell meeting: Part 1

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 is very scientifically focused so far. There has been a lot of clinical trial data presented, which…

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[pknoepfl]

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

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

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 Kirk of Illinois, has had several incarnations, but the latest new one reflects some big changes…

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[pknoepfl]

Poll for #ISSCR2016 attendees: what's your view of REGROW Act?

Poll for #ISSCR2016 attendees: what’s your view of REGROW Act?

Take Our Poll

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[pknoepfl]

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

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

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 cell interventions into patients…

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