Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by […]
FDA needs to quickly act against IRBs enabling risky fat stem cell clinics Read More »
Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out
Scott Gottlieb leaving FDA: possible reasons, impact on stem cell field, & more Read More »
When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman.
The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a
FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely Read More »
Is fat-free always a good thing…even for unproven stem cell clinics? It must be a challenge for a stem cell clinic firm like US Stem Cell, Inc. (USRM) to face an imminent possible future where it cannot sell injections of its main product, fat stem cells, in the US. After all, “US” and “Stem Cell”
Is clinic firm US Stem Cell sued by FDA prepping for fat-free future? Read More »
Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many
Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex Read More »
You probably remember Liveyon. It’s a marketer of an “umbilical cord stem cell” product that was recently recalled by the FDA. The recall was due to adverse events that may have included E. coli contamination somewhere before it was injected into patients, some of whom apparently got sick. Since it seemed like this recalled product was
Stem cell clinic supplier Liveyon tries to regenerate itself after FDA recall Read More »
Take our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019? To be clear, I am asking for your predictions, not what you hope will be the situation a year from now. U.S. Stem Cell, Inc. (USRM) and California Stem Cell
Polls on futures of stem cell clinics sued by FDA Read More »
I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of
Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks Read More »
The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? I’ve been hearing the name Liveyon pop up
FDA recalls Liveyon stem cell product: blow to big clinic supplier? Read More »