by rss feed | Aug 5, 2026 | FDA Warning Letter, Florida, News Feeds
What might a state stem cell law that says FDA approval isn’t needed have to do with FDA warning letters? A growing number of states have these anti-FDA stem cell laws. One of the issues with any specific such law like Florida’s is that clinics and related...
by rss feed | Dec 16, 2025 | Celularity FDA warning, FDA Warning Letter, News Feeds
Three recent FDA warning letters, including one issued to publicly-traded Celularity, paint a helpful picture of where FDA oversight stands. They illustrate how the FDA’s classification of placental/amniotic products greatly depends on how a firm positions a product...
by rss feed | Oct 26, 2025 | Allerdent, FDA Warning Letter, News Feeds, weekly reads
Did you know there’s immunotherapy toothpaste? It’s intended to provide immunotherapy of a kind while you brush. Some of this is meant to help allergies so the products can also be called allergenic toothpastes. Let’s start this week’s...
by rss feed | Sep 9, 2025 | Beeben Russell, FDA Warning Letter, Innate Healthcare Institute, News Feeds, perinatal stem cells, Platinum Biologics, Regenative Labs
Perinatal biologics supplier Platinum Biologics recently received an FDA warning letter. A second perinatal biologics firm, Innate Healthcare Institute, was also recently warned. I’m primarily going to focus on the warning to Platinum Biologics, but both letters...
by rss feed | May 29, 2025 | FDA Warning Letter, News Feeds, Skye Biologics, Supreme Rejuvenation, Trump FDA
The FDA’s biologics or CBER branch just warned two perinatal biologics firms. In a way, these letters surprised me more than any in recent years. Up to this point, I had not seen any posted warning letters from the Trump 2.0 FDA to stem cell clinic or biologics...
by rss feed | Feb 6, 2025 | Chara Biologics, Dr. Joy Kong, Evolutionary Biologics, FDA Warning Letter, News Feeds, perinatal stem cells
What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13...
