Late on a Friday in November 2013, Anne Wojcicki, the co-founder and CEO of 23andMe, received a package from the U.S. Food and Drug Administration that contained a warning letter. This marked a turning point for 23andMe’s journey as they had been engaged in a regulatory battle with the FDA.
The contents of the warning letter would shape the future of 23andMe and forced them to reevaluate their approach to regulation. This pivotal moment highlighted the complexities of navigating the health technology industry and the importance of compliance with regulatory agencies.
Anne Wojcicki’s leadership and strategic decision-making during this challenging time ultimately led to the evolution and growth of 23andMe. The story of the FDA warning letter serves as a reminder of the regulatory hurdles that health technology companies face and the critical role of leadership in overcoming challenges in the industry.
Follow along for more insights into Anne Wojcicki’s entrepreneurial journey and the impact of regulatory decisions on health technology companies like 23andMe.
Attribution:
This article was summarized and republished from the original source.
Please check the original article here: https://hbr.org/2020/09/23andmes-ceo-on-the-struggle-to-get-over-regulatory-hurdles.