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 | 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...
by rss feed | Dec 3, 2024 | Chad W. Justice, FDA Warning Letter, Frontier Biologics, News Feeds, perinatal stem cells, Scotty Ray Handley
The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the...
by rss feed | May 15, 2024 | Interviews, Kyle Cetrulo, News Feeds, Perinatal Stem Cell Society, perinatal stem cells
I was interested to see that an organization called The Perinatal Stem Cell Society seems to have been upbeat about the new Utah stem cell law. That law sets up a likely conflict with the FDA and federal law over stem cells. In a nutshell, Utah now says you can sell...
by rss feed | Sep 21, 2023 | BioBurst, Burst Biologics, Investigative, News Feeds, perinatal stem cells
The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the...
by rss feed | Aug 31, 2023 | FDA Warning Letter, News Feeds, perinatal stem cells
Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this...
