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 »
How bad could things get with RFK Jr. changing the FDA’s approach to unproven stem cells? I’ve been asking myself this for months since Kennedy’s post that mentioned stem cells on X. New developments suggest things will get much worse. Up until about a week or two ago, my feeling has been that things could
“Very scary”: Per Marks, RFK Jr. aiming for weaker regs on unproven stem cells Read More »
The Japanese stem cell and regenerative medicine oversight system is different than here in the U.S. and in Europe. Japan has had a more permissive approach to overseeing regenerative medicine. While most of the attention has focused on fairly legitimate regenerative biotechs and other sponsors in Japan, there are unproven stem cell clinics there. These
Japanese stem cell clinic oversight: the case of MSC clinic Seijikai Fukuoka Read More »
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 »
RFK isn’t even confirmed as HHS Secretary and things are going south already with an NIH freeze. What do I mean? NIH freeze could do lasting damage to biomedical research The Trump Administration has frozen many NIH processes including meetings such as study sections that evaluate grant proposals. No study sections means almost no new
It’s important to pay attention to science hype, which is the rationale for The Screamers Science Hype Awards. As far as I know, it’s the only award for science hype. Exaggerating research and medical potential clearly does harm. I wrote a few weeks ago about the nominees for the 2024 The Screamers Awards. Now it’s
Winner of The Screamers Science Hype Award: local TV stations pushing stem cell clinics Read More »
What are the current FDA-approved cell and gene therapies? How many of those involve true stem cells? Many of us have wished for a more specific list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me about such lists. They even wish for annotated lists. For that reason, I’ve made and kept
Updated 2025 List of FDA-Approved Cell and Gene Therapies Read More »
If you tell a scientist that they should be growing a spine, they might take you literally. For instance, if you say this because you want a scientist to show some courage and speak out about something difficult, instead they might try to make an actual human spine in a lab. We’ll start there this
Weekly reads: grow a spine, China clears MSCs, Denise Richards, stem cell soups Read More »
The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA. If SCOTUS takes the case, the FDA could find its powers
FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in Read More »