Tag Archives: 23 & Me

FDA Warning Letter Highlights Disconnect Between Regulator & Biotech Industry

A surprise at this year’s Thanksgiving dinner was that a majority of my friends (who do not work in biopharma) at the dinner table heard about the FDA warning letter issued to 23 & Me, a biotechnology company that offers a direct-to-consumer genome test kit. Almost all of them have used the kit and find […]

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