Day: April 16, 2026

Building on our previous discussion of the “Single-Trial Pivot,” we’ve seen the FDA move away from the rigid 1962 dual-study precedent toward a more flexible, evidence-based approach for precision therapies. But while that shift was initially signaled through journal articles and informal policy trends, the Agency has now codified a critical component of this evolution. With the release of the new … Read more

The landscape of medical device oversight is undergoing a seismic shift as the FDA pivots toward a more dynamic, data-driven inspection framework. For senior executives, staying ahead of these regulatory currents is not just a compliance requirement, it is a strategic imperative. The recent FDA town hall underscored a move toward high-velocity, risk-based methodologies designed to optimize oversight in … Read more