Ken Banta Explores Why Today’s Leaders Can No Longer Treat the FDA as a Back-Office Issue

Ken Banta, Founder and CEO of The Vanguard Network, has published a new Substack article titled “Why High-Performance Leaders Can’t Ignore the FDA Anymore.” Released on October 30, 2025, the piece examines how regulation has become a central leadership concern rather than a purely technical or legal one.

Drawing on a recent Vanguard conversation with Nate Beaver and Kyle Faget of Foley & Lardner LLP, Banta highlights how political shifts, digital health innovation, AI, and changing enforcement priorities are reshaping the role of the U.S. Food and Drug Administration.

The article argues that decisions around product design, timing, risk tolerance, and market entry are now inseparable from regulatory strategy. For high-performance leaders, understanding and engaging the FDA early is no longer optional. It is a strategic imperative that can determine long-term success or costly failure.

To read the full article on Substack, click here.

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