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 »
Peter Marks resigned last week as CBER director and now Dr. Scott Steele is the new acting biologics branch director. Marks resigned under pressure and went out firing back, referring to lies and other issues of HHS Secretary RFK Jr. One of the first things I thought when I heard about Marks’ departure was, “who
The marketing of what are loosely referred to as “regenerative peptides” including BPC-157 makes many health claims. Yet I can’t see that any have been conclusively proven to work in people. Even so, RFK Jr. claimed that the FDA was suppressing useful peptides. He mentioned this along with supposed suppression of “stem cells”. So maybe
RFK Jr. & claimed regenerative peptides like BPC-157 Read More »
There were many reasons for the U.S. Senate not to confirm RFK Jr. as HHS Secretary. Reasons that transcended politics. Nonetheless, Senate Republicans confirmed him today for that post. Some of them had voiced serious concerns before including one physician Senator, Dr. Bill Cassidy, but they all voted for Kennedy anyway. All except Mitch McConnell,
Initial reactions to RFK Jr. being HHS Secretary 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
How will things change at the FDA under the second Trump Administration? It’s a key question for our field but not easy to answer. Most likely there will be more instability at the agency. Some leaders, like of CDER, have already left. in my overall regenerative medicine predictions for 2025, I’ve included more predictions about
Weekly reads: FDA modernization, TFs on the brain, mortality timer, pluripotent trials Read More »
Platelet-rich plasma or PRP has become one of the most commonly used regenerative products at unproven clinics. The orthopedics departments at many universities are now offering PRP as well. What is behind this trend? How much data are there to back up all this enthusiasm for platelet-rich plasma? The goal of this post is to
2025 PRP fact-check and review: cost and possible benefits Read More »
Each year I give out The Screamers Awards. As far as I know it’s the only science hype award in the world. The Screamers Awards recognize extreme examples of science hype, most often by the media. The major focus is on the biomedical sciences, but other areas of science are eligible too. Last year, the
Meet The Screamers Science Hype Awards 2024 nominees Read More »
Remember cryonics, the idea that you could hit pause on human life? This relies on the super-cold power of liquid nitrogen or some other ultra-freezing method. Apparently cryonics is still a thing and there are people with even just their heads frozen. A new story claims a different way to hit the pause button on
Weekly reads: hit pause on human life, CIRM pause, 23andMe data, blast from the past 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 »