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 […]
Trump Has FDA in Crosshairs: Impact on Stem Cell Oversight? Read More »
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
REGROW Act to do reappearing act? Read More »
Today was the first part of the FDA’s 2-day meeting on stem cell draft guidances. It was a great meeting I thought. A few consistent themes and notable things emerged as raised by participants.
8 key arguments, take-homes on day 1 of FDA stem cell meeting Read More »
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
Blogging today’s FDA stem cell meeting: Part 1 Read More »
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
REGROW Act 2.0 still no-go with big risks to patients & field Read More »
Poll on the REGROW Act. What do you think of this healthcare legislation?
Poll for ISSCR 2016 attendees: what’s your view of REGROW Act? Read More »
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
The backstory on my opinion piece in SF Chronicle critical of CIRM lobbying Read More »
The REGROW Act would drastically weaken FDA regulation of experimental stem cell therapies. I’ve criticized it in numerous posts (see those here) for its radical ideas that would put patients and the stem cell field at risk. I’m not the only one concerned about it as both ARM and ISSCR oppose it too. Now 10 top patient advocacy
Ten patient groups oppose REGROW Act that would gut stem cell oversight Read More »
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
Is REGROW Act anti-embryo research? Pluripotent stem cells excluded Read More »
We’ve heard of payphones, pay toilets, and other services for which people have to pay for access, but what about pay-for-play clinical trials? In a pay clinical trial, patients have to pay anywhere from $10K to over $100K to get in the door. I asked readers of this blog about how they feel about patients
Pay-for-play clinical trials? 70% negative polling Read More »