Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do […]
Dissecting the FDA’s big, fat stem cell dilemma Read More »
Who are the top stem cell influencers? Terrapin asked this kind of question to some within our community 4 years ago and came up with a Top 50 list of stem cell influencers, which I like to joke I was “at the top of” because I was #50 and they listed us in reverse chronological order.
List of Top 50 stem cell influencers on Twitter to follow Read More »
The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already
Six questions as FDA takes new shot at stem cell clinics Read More »
Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The
US Stem Cell bid for FDA RMAT rejected? Read More »
Today there is an editorial piece in the WSJ about the recent court ruling giving the FDA authority to regulate stem cells grown in culture as drugs. As a stem cell scientist, I read this opinion piece with interest. Unfortunately it is behind a paywall, but I have outlined and discussed the key issues below.
WSJ editorial on issue of stem cells as drugs misses the boat Read More »
There’s a lot of questionable “stem cell” injections these days involving purported amniotic stem cell or other perinatal (birth-related) material. Regulators are taking note including the FTC, which took some unprecedented action last year on this front. Now the FTC has announced that more than half a million $USD have been returned to consumers who
The birth-related stem cell clinic industry is a serious problem for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections. Zombie stem cells One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was
Sales of zombie stem cells continue to mushroom Read More »
Happy science Friday and here’s a TGIF list of recent stem cell news and papers. The FDA warning letter to Richard Burt of Northwestern related to noncompliance issues with his stem cell clinic trial for MS has dominated the news recently, but some other notable things have happened as well on stem cells and more
TGIF stem cell & science news bites Read More »