Keep your hands off of my cells! At least, that is what many are telling the FDA regarding stem cells. The FDA issued four draft guidances related to stem cells in the past year or so, held two public stem cell meetings, and now must decide what it is going to do with an out […]
4,000+ comments on FDA stem cell guidances, mostly clones of “My cells are my cells” Read More »
In the total the FDA has held 3 days of public meetings on stem cells in the last few weeks ranging from science to policy and hearing from many parties including patients and even stem cell clinics so the big question now is, “what happens next?” The FDA has 4 draft guidances pertaining to investigational
What happens next with FDA & stem cells: lower your expectations? Read More »
The FDA’s stem cell meeting wrapped up today on day two with a diverse group of individual speakers. A series of patient testimonials today in favor of clinics was one thing that stood out. You can read my take of day one and the account of Jeanne Loring who was at the meeting. I’ve noted that on
Report on day 2 of FDA stem cell meeting: patients, researchers, & more Read More »
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.
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 »
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
Blogging today’s FDA stem cell meeting: Part 1 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 »