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. […]
If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a
40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke Read More »
Dear FDA, The stem cell clinic clock is ticking on you. Before the Trump administration rolls in to possibly tie your hands on many important areas of oversight including stem cell clinics, you should take bold action now. Your CBER branch has been preternaturally quiet on taking actual regulatory actions on stem cell clinics for
Open letter to FDA: take action now on stem cell clinics before Trump Read More »
The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which
FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics? Read More »
Stem cell studies continue to make big news with a mixed bag of trends including for stem cell biotech, and some good stem cell news and others not so much. Mesoblast ($MESO) had its stock suspended for quite so time recently in anticipation of a big announcement. When that news came today it was discouraging in
Stem cell biotech bites: Mesoblast, BioTime, MS, FDA Warning, & More Read More »
The FDA has taken another action against a manufacturer of stem cell cosmetics in the form of anti-aging creams with a warning letter sent on April 20, 2016 to Crescent Health Center, Inc. The FDA noted a number of issues in the warning letter that it termed “serious violations”, but the biggest issue was that the agency
FDA warning to stem cell cosmetics maker Read More »
Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment
FDA warning points to tougher regulation of fat stem cells & clinics Read More »
The following is a response to my Open Letter to the UK Parliament on mitochondrial transfer/3-parent technology from Drs. Peter Braude and Robin Lovell-Badge. Dear Professor Knoepfler, We read your open letter to the UK Parliament and the Science and Technology Committee with interest and concern. We are two scientists, like you, with particular interests
Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has
Osiris FDA Letter: Trick or Treat? Read More »
A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed letters from Celltex to the FDA that previously were not in the public domain. The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I