The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the […]
Federal judge blocks FDA action on Texas amniotic supplier 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 »
The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics. You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream. Three new warning letters to stem cell cream makers
3 more FDA warning letters to stem cell cosmetics makers Read More »
It’s been a big 2 weeks in terms of media interest in talking about the upcoming FDA meeting on stem cell oversight taking place in just a few weeks. There are many questions about this meeting and I’m planning to tackle some of the questions in upcoming posts including next week. These questions include, “who
Outcome of FDA stem cell meeting likely to please no one Read More »
That much-anticipated public FDA stem cell meeting that was postponed from April will now take place in September and will have a much larger array of diverse speakers. Many more voices at an FDA stem cell meeting are collectively a good thing, but delay is not. The large and growing U.S. stem cell clinic industry makes
September FDA stem cell meeting looks to be big debate 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 »
Why can there be huge clinical trial fees for participants? I am often critical of for-profit stem cell clinics on this blog for numerous reasons. For instance, one thing that concerns me greatly about these clinics is that they charge patients to get experimental “treatments” that have not been proven to be safe or effective. But
Huge clinical trial fees allowed by FDA at times, details often secret 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 »
The FDA stem cell meeting that was supposed to take place in April is now officially going to be a 2-day event in September. This public meeting is meant to get comments on four draft guidances related to regs on stem cell products and treatments. FDA stem cell meeting From the FDA announcement on the meeting:
FDA stem cell meeting now a 2-day public event in September Read More »
Stem cell clinics like Nervana are spreading like wild-fire across the U.S. A few months back the Sacramento area got a new stem cell clinic selling amniotic stem cell therapies for a variety of ills including most prominently arthritis and pain. This clinic is called Nervana Stem Cell Center. I first noticed it via a
Stem cell clinic Nervana new ad claims no side effects & FDA OK Read More »