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 a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have
Guide to September 12-13 FDA Stem Cell Meeting Read More »
What can go wrong with unapproved stem cell clinic offerings? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S. Thomas Albini, MD gave a talk entitled, “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”.
Negative stem cell clinic outcomes include 3 blinded women Read More »
The FDA is holding its first 2016 stem cell meeting today and you can read about some impressions of the morning session of this meeting here. In this post, I’m focusing on the afternoon session, which has been mostly on policy and ethics, including on stem cell clinics. Jonathan Kimmelman from McGill University got the afternoon going
Blogging today’s FDA stem cell meeting: Part 2 Clinics, Policy & Ethics Read More »
The upcoming big FDA 2-day public stem cell meeting next week is generating a lot of interest within the stem cell community and also with members of the media. I expect there to be tons of coverage, which should be a good thing (note that there’s a different FDA stem cell meeting tomorrow). If you can’t make
For big FDA stem cell meeting, are clinics paying some participants? Read More »
There’s a big FDA stem cell meeting coming along next week that has gotten much attention, but many people didn’t realize there’s also an FDA meeting on stem cells this week too in three days on September 8th. I pasted this week’s meeting schedule at the bottom of this post from the FDA page. The meeting is
Wait, there’s an FDA stem cell meeting this week too? The scoop Read More »
Here is a hub for 2017 stem cell and regenerative medicine meetings. If you do not see your meeting, please let me know and I will include it. Change– I’m also going to be listing online courses (in red) this year. This list is meant to be as inclusive as possible, but by listing specific
Stem Cell Meetings & Conferences 2017 Read More »
The stem cell clinic trial being run by Asterias Biotherapeutics for spinal cord injury (SCI) reported (via CIRM) some preliminary very good news as it is so far seems safe and will be expanded to involve more patients. In the next phase, reportedly “Asterias is now looking to enroll 5-8 patients for this 20 million
Stem cell good news as Asterias SCI trial to expand with strong safety data Read More »
The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics. You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream. Three new warning letters to stem cell cream makers
3 more FDA warning letters to stem cell cosmetics makers Read More »
It’s been a big 2 weeks in terms of media interest in talking about the upcoming FDA meeting on stem cell oversight taking place in just a few weeks. There are many questions about this meeting and I’m planning to tackle some of the questions in upcoming posts including next week. These questions include, “who
Outcome of FDA stem cell meeting likely to please no one Read More »