By Jeanne Loring Paul did a good job of giving an overview of the FDA meeting today. Being in the room, I have a few observations that complement Paul’s. I’ve never been to a meeting like this- there were 42 scheduled 5 minute presentations, and this is just the first of 2 days. The question …
Jeanne Loring’s Report from Inside FDA Stem Cell Meeting Day 1 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.
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 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 …
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 »
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 »
I’ll be on NPR’s @hereandnow w/Robin Young in about 40 minutes talking stem cell clinics. #Stemcell clinics thrive in US despite lack of @US_FDA regs. Is it #SnakeOil? @Pknoepfler thinks so. https://t.co/NxJ5z3IVGw @hereandnow — Karyn Miller-Medzon (@KBMM) September 1, 2016 Listen in if you have the chance and the segment will also be archived on …
I’m on NPR’s Here & Now Talking Stem Cell Clinics in ~40 minutes Read More »
The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the …
Federal judge blocks FDA action on Texas amniotic supplier Read More »
The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which …
FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics? Read More »