The FDA has a new CBER Director Dr. Vinay Prasad. CBER is the FDA’s biologics branch that handles things like cell therapies and vaccines. The branch has been in near-constant upheaval this year. For a time, Scott Steele was acting CBER Director. It wasn’t clear if he was there in a temporary capacity or would […]
FDA critic Vinay Prasad to run CBER: more politics than experience? Read More »
The Trump Administration just quickly gutted the FDA including key leadership. What is going to be the impact of this sudden purge? Former Commissioner Robert Califf recently said it is the end of the FDA as we’ve known it. Those are dramatic words, but they seem on the money to me. As a biomedical scientist
Why the FDA & CBER leadership purge will be so bad for biotech Read More »
Some of you may know that gardening is one of my hobbies and I see it as akin to science, even like growing stem cell cultures. Tomatoes are my favorite thing to grow. About ten years ago I started sprouting my own tomato plants from seed. It’s surprisingly easy with grow lights. This way you
Weekly stem cell reads: tomato stem cells, FDA blacklist, CALEC, odd RFK Jr. summit Read More »
A new Florida stem cell bill directly challenges the FDA and its CBER branch. If passed, which seems relatively likely, the Florida bill would become of state trend. A Utah stem cell law and a broader Nevada biologics law legally okay non-FDA approved biologics. These and other pending state efforts pose major risks to FDA
Florida stem cell bill is part of state trend to sidestep FDA Read More »
New FDA Commissioner Marty Makary has brought on Dr. Tracy Beth Hoeg (or Høeg) as a special assistant. Hoeg has had some controversial views on COVID. She has seemed skeptical of certain elements of vaccination, masking, and school closing. What struck me is that she also has offered unproven cell therapies at a clinic here
New Makary FDA aide Dr. Tracy Hoeg has offered unproven stem cells Read More »
Most of us want longevity, especially if our quality of life remains generally solid as we age. The combination of length and quality of life is sometimes called “healthspan.” How do we get the maximum health span? Easier said than done. Not all of the obstacles are biological either. Unfortunately, accompanying all the legitimate research
Weekly reads: Topol on longevity biz, Peter Marks out at FDA, timeless NIH grant advice Read More »
I had a feeling late last year that I’d frequently be writing about RFK Jr. and his impact on the FDA. However, I didn’t realize some of that would be writing for STAT News. As I mentioned a few days ago, I now have a new regular column over there. I thought the column would
Weekly reads: RFK Jr. stem cell summit, FDA OKs eye cell therapy, cartilage repair Read More »
When I think of so-called aging supplements, visions of snake oil dance in my head. Possible benefits of supplements more generally have mostly not held up to long-term research. Supplements have risks too and so do purported longevity supplements. These pills claiming to fight aging are more in the realm of stem cell supplements that
Weekly reads: Altos Labs aging supplements pub, destructive NIH cuts, FDA warning, HSCs Read More »
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
A Texas firm called INCELL Corporation has received an FDA warning letter about an amniotic product it manufactures. The letter was addressed to the firm’s founder and leader Dr. Mary Pat Moyer. The letter is somewhat unusual as Dr. Moyer is the Chief Science Officer of INCELL, and is an academic scientist with over 250
NAE member Mary Pat Moyer on FDA Warning Letter to her firm INCELL Corporation Read More »