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 »
What does Google think (if Google does indeed think) are top 10 stem cell news stories right now? I took a screen shot below. Here are some thoughts on those stories. First, lung organoids are neat, but they have been grown before by several groups. Why is that the top story? I’d have to ask Google. Better
Google Stem Cell News Stories: Perspectives 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 »
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 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 »
One of the best things as a stem cell scientist is to see all the new stem cell papers that come out. Here are 5 thought provoking new ones. Dual targeting of p53 and c-MYC selectively eliminates leukaemic stem cells (Nature) Zika Virus Infects Neural Progenitors in the Adult Mouse Brain and Alters Proliferation (Cell Stem
5 thought-provoking new stem cell papers Read More »