Gonia, all your questions I provided in my first post. It does require you to read it all.
After some of the 3 min sessions from each company you can see, if you read it, that then the panel members will ask for additional info.
Questions from panel 9:55-10:25
Questions from panel 12:00-1:00
Questions from panel 3:00-3:30
Questions from panel 5:00-Close: Closing statement
This is a public hearing from the FDA where panel members will listen to all about why tissues, human cells ect should or should not be regulated as a drug ect. ITS A BIG DEAL which determines final guidance.
What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment and finalizing draft guidelines related to stem cell clinical products including fat stem cells aka adipose stem cells and stromal vascular fraction or SVF
.
If they determine that this process is a drug, then your talking about millions in safety and efficacy studies before approval....