Is the U.S. Approval Process for New Medicines Fundamentally Changing? - FleishmanHillard

Is the U.S. Approval Process for New Medicines Fundamentally Changing? - FleishmanHillard

The sweeping changes seen since January 2025 represent tectonic shifts in the foundations of healthcare in the U.S.–transformations that are likely to have targeted impacts on how new medicines are discovered, regulated and potentially even promoted. Furthermore, as the Food and Drug Administration (FDA) sets global standards in many ways, any disruptions or shifts in its operations could create a ripple effect in other regulatory agencies aroun…