FDA warning letter

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.

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

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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 […]

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23andMe and the FDA: Perspectives on Warning Letter

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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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