January 23, 2021

The Niche

Trusted stem cell blog & resources

fda draft guidances

2 min read

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 of control direct-to-consumer stem cell clinic industry. In part it will need to sort through all public comments from the meeting and those submitted online. There are 4,251 comments …Read More

2 min read

The FDA has delayed the planned big April public meeting on stem cells until later this year. Basically, the reason given is that more time is needed for stakeholders to comment. It will be interesting to see if the FDA expands the meeting beyond the 1-day format, which was going to allow each speaker only 3 minutes. It would be helpful I think if the FDA held the meeting in a more centrally located city as well. I’m hoping now I might be able …Read More