September 26, 2020

The Niche

Knoepfler lab stem cell blog

FDA warning letters

4 min read

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain suppliers are strong driving forces behind more patients being put at risk. Also, each supplier may enable dozens of clinics so there’s some logic here to the FDA putting …Read More

2 min read

When you get an FDA warning letter (like if you are a non-compliant stem cell clinic) you generally aren’t feeling too well after reading it, but now there’s an extra thing to worry about according to the FDA. A fake FDA warning letter. Apparently 3-dozen or more of these fake FDA warning letters sparked complains to the agency. Reporter Stephanie M. Lee over at BuzzFeed Science was on this too. First thought: maybe it’s kind of like those phone messages being left all over …Read More