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 months. I wrote late last year how 2024 […]
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 FDA has been doing much more on this front in 2024. With
FDA warns Frontier Biologics as part of its more active trend Read More »
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 non-FDA-approved stem cells in
Q&A with Kyle Cetrulo of The Perinatal Stem Cell Society on the FDA, state laws, & more Read More »
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 suppliers. Further, what is the FDA’s role in all of this? The
Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »
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 summer the agency warned Regenative Labs. There have been quite a few letters to others in this
FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity Read More »
If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
A firm called Utah Cord Bank has been in the news related to stem cell clinics over the past year or two. Now they have received an FDA Warning Letter for a variety of manufacturing issues. Utah Cord Bank Background In terms of some brief backstory, Utah Cord Bank first popped up on my radar
FDA warning to stem cell clinic supplier Utah Cord Bank Read More »
The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest
Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game? Read More »
I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have
Bad Batch podcast’s dark picture of perinatal stem cell industry Read More »
Up until now Utah hasn’t immediately come to mind as a hub for stem cell issues, but things are heating up there in 2019. Utah? I was going to do a blog post here on The Niche last month about perinatal (birth-related) biologics and stem cell-related supply companies in Utah. Some of their customers appear
‘Bottom of stem cell barrel’? Utah piece sparks legal threat Read More »