Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come […]
What is an FDA warning letter & how should firms respond Read More »
I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is
Review of troubling R3 Stem Cell clinic chain Read More »
The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways
One size doesn’t fit all? FDA may soften some cell therapy regs Read More »
If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging. He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016. I’m very glad that Leigh has continued this line of
Turner pub charts runaway stem cell clinic industry; FDA needs to think big now Read More »
This week marked the release of new draft FDA guidance on cell and gene therapies. Is the FDA kind of like the guidance counselor at school or more like the principal? It probably depends on many factors. I also find it funny how pretty much everyone in academia and biotech industry works to be compliant
Weekly reads: New FDA guidance, brains, MSCs, senescence Read More »
One of my favorite types of papers are those on stem cells and chromatin, and a new one in Current Biology caught my eye this week. My own lab website has the URL chromatin.com so that says something. You can also read more about our research here. Recommended reads: chromatin and stem cells, more Asymmetric
Weekly recommended reads including asymmetric division & chromatin Read More »
The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers
Translating the FDA’s Q&A on end of stem cell grace period Read More »
Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics