What 23andMe FDA case can teach health care entrepreneurs

The interaction between the FDA and 23andMe provides important lessons for future health care entrepreneurs, according to Steven Nichtberger, a life sciences entrepreneur and adjunct professor at Wharton who manages the school’s Life Sciences & Management capstone course on health care company formation, financing and leadership. “My impression of this situation from the warning letter is that the FDA bent over backwards to provide plenty of guidance, but it seems like 23andMe failed to be responsive to it and dropped the ball,” Nichtberger says.

Indeed, the warning letter indicates that 23andMe submitted applications to the FDA for marketing approval on several occasions, but those documents “failed to address the issues described during previous interactions with the Agency.”

Read the full, original story: The FDA vs. 23andMe: A Lesson for Health Care Entrepreneurs

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