The FDA regularly warns firms and individuals related to violations of compliance or even the law. The most assertive action is an FDA warning letter. Posts in this category report on such warning letters.
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 »
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 FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning
FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem Read More »
We need medical innovations, but what is the appropriate way for agencies like the FDA to regulate the process and fight bogus interventions based solely on hype? Without innovation, medicine becomes stagnant and hope fades for patients who have any one of numerous conditions that are currently inadequately addressed by medicine. I can relate on
What is the FDA’s appropriate role in regulating medical innovations such as stem cells? Read More »
What’s the deal with this week’s FDA Warning Letter to 23andMe? First some background. I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome. With this background, I decided some time ago to take the plunge and experience what
23andMe and the FDA: Perspectives on Warning Letter Read More »
I opened the most recent edition of Journal of the American Medical Association (JAMA) and found a striking full-page ad from the FDA. It’s unclear if this is the first ever such advertisement. I have been unable to find a similar one on the Internet at least. Has anyone seen such ads before? The JAMA
Full page JAMA ad from FDA warns docs on foreign drugs Read More »