FDA warning letter

Stem cell clinic doc being sued by FDA now gets agency warning for unapproved breast device

Elliot-Lander-and-Mark-berman-300x2331

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. …

Stem cell clinic doc being sued by FDA now gets agency warning for unapproved breast device Read More »

What is the FDA’s appropriate role in regulating medical innovations such as stem cells?

FDAADF-150x150

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 »

23andMe and the FDA: Perspectives on Warning Letter

23andMe

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 »

Full page JAMA ad from FDA warns docs on foreign drugs

FDA-JAMA-Ad-768x10241

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 »