I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them […]
FDA wins big in key federal stem cell clinic court case Read More »
FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I
Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »
I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah
Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society Read More »
The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,
Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics Read More »
BrainStorm Cell Therapeutics is developing Nurown, an investigational therapy intended for treating ALS. I recently posted about BrainStorm and its prospects for providing real hope on stem cells for ALS. I see it as a long shot. The ALS community needs real hope, but one challenge is determining how good clinical data have to be to
BrainStorm Cell Therapeutics Hail Mary with FDA on Nurown for ALS Read More »
It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several
Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions Read More »
I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II
Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags Read More »
An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »
The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven
Did COVID derail FDA stem cell clinic plan? Read More »
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 »