QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies. I see several specific red flags including a class action lawsuit. They report having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands of customers. […]
QC Kinetix review: concerns on huge regenerative clinic chain Read More »
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 »
Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of
Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan Read More »
How might Trump’s nominee to lead the FDA, Martin Makary, change the agency? Should we be worried or hopeful? I’ve been closely following the FDA and its commissioners ever since I started The Niche in 2010. I’ve been particularly interested in how these leaders impacted FDA actions on cell and gene therapies. How might Makaray
What you need to know about Martin Makary and planning for the Trump 2.0 FDA Read More »
For a few years, biophysicist He Jiankui might have been one of the most recognizable scientists on the planet. He made three “CRISPR babies” or gene edited people. However, his gene editing went badly and as best as we can tell his efforts did not result in precision edits. It’s unclear if he had institutional
Who decides what to name something new in science like “human embryo models”? Also, not to get too philosophical right off the bat, but what is the point of a name? It’s about a shared understanding of what we’re talking about. But, very often, both out in the world and in the various fields of
Beyond naming: embryo models and the importance of public dialogue Read More »
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 »
What do you think of when I mention Stanford professor Mike Snyder and self-help guru Tony Robbins together? I would not necessarily have imagined them forming a connection but science is full of surprises. I’ve admired Snyder’s work in genetics for a long time. I’m most familiar these days with Robbins for his interest in
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 »
If only humans could master regeneration. It seems like that would open the door to far better health. Maybe to longer life too. We can see how many other creatures innately can regenerate organs. I can see it in the lizards that run around in my garden. Every now and then I see one with