FDA warning letter

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

February 1, 2021 / By / 4 Comments
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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 …

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23andMe and the FDA: Perspectives on Warning Letter

February 1, 2021 / By / 5 Comments
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 …

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Full page JAMA ad from FDA warns docs on foreign drugs

February 1, 2021 / By / 10 Comments
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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 …

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