The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers […]
Translating the FDA’s Q&A on end of stem cell grace period Read More »
The FDA has sought injunctions in federal court against two stem cell clinic firms including the clinic chain Cell Surgical Network headquartered here in California and US Stem Cell in Florida. According to new documents filed by the government in federal court here in California there may be more ties between the clinic firms than
FDA alleges Cell Surgical Network links to US Stem Cell & COVID plan Read More »
What can a gecko possibly teach us about skin cancer? Read on. It’s fun when a week’s worth of science reading covers so much territory including COVID-19, geckos that get cancer, a research misconduct sleuth, an FDA letter, and more. Baltimore weighs in on COVID lab origin idea Caltech has a very interesting interview with
Recommended reads: Bik, FDA letter, gecko cancer model, David Baltimore on COVID origin Read More »
The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a
New data on stem cell clinics, INDs, & more including from FDA itself Read More »
A firm called Utah Cord Bank has been in the news related to stem cell clinics over the past year or two. Now they have received an FDA Warning Letter for a variety of manufacturing issues. Utah Cord Bank Background In terms of some brief backstory, Utah Cord Bank first popped up on my radar
FDA warning to stem cell clinic supplier Utah Cord Bank Read More »
Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics
What are the current FDA Approved Cell and Gene Therapies? In the past many of us have wished there was a list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me, but I couldn’t find a list. As a result, I made a comprehensive list of FDA Approved Cell and Gene Therapies,
List of FDA Approved Cell and Gene Therapies Read More »
Those of you following the arena of unproven stem cells might recognize the name Dr. Joseph Mercola. He’s a promoter of alternative medicine. Over the years his name has also popped related to the marketing of unproven stem cell offerings in various ways. Now the FDA has warned Joseph Mercola on what it says are unapproved
FDA warns Joseph Mercola on COVID-19 claims Read More »
During the week as I’m doing other stuff I keep my eyes open for interesting things to read, including over the weekend about stem cell research, COVID, CRISPR, and more for The Niche weekly recommended reads. This week a lot was going as we updated The Niche site to our new theme and format. I
Recommended reads: jobs, FDA letter, & The Niche new look Read More »
In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about
FDA OK’s more COVID-19 efforts of unproven stem cell clinics Read More »