This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve […]
Big spike in FDA warning letters to unproven biologics firms Read More »
I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them
FDA wins big in key federal stem cell clinic court case Read More »
The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start
Regener-Eyes maker gets FDA warning on amniotic eye drops Read More »
The FDA just warned a Florida stem cell clinic firm called Mother Stem Institute run by Dr. Alvaro Skupin. Background: Mother Stem Institute past issues I’ve written about this clinic and Dr. Skupin in the last few years. Just about a year ago I blogged the news that a patient suit against the clinic was
FDA warns Mother Stem Institute & Alvaro Skupin Read More »
Even for a stem cell research wonk like me the broader regenerative arena never ceases to surprise me with the latest thing being stem cell shampoo. Stem cell shampoo A news item that seems promotional discussed the stem cell shampoo as yielding positive results. So after you are done with your vampire facelift, stem cell
Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis Read More »
Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely. They are not scientifically or medically proven to work or be safe so they could lead to substantial harm. This is yet another early step in a likely growing trend of states challenging FDA authority
FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I
Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »
When I first saw the new FDA warning on stem cells for pets and the logo for the company that received it, I was surprised in a few ways. I don’t recall ever seeing such a letter and the logo is something else. We’ll get into all of that in a moment, but first, since
Recommended reads: FDA warning on stem cells for pets, chromatin, aging & HSCs Read More »
One of the most contentious areas in the regenerative medicine arena is whether a fat tissue product called stromal vascular fraction or SVF is a drug. The FDA says SVF, even in autologous form, is a drug. It is seeking an injunction against a California-based network of SVF clinics but lost the initial case. That
Recommend reads: FDA SVF warning, big Aspen grant, CSI finale invokes stem cells 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 »