Inside a changing FDA: Winners, losers and uncertainty

The Trump administration’s overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. Some companies will benefit, others will face new hurdles, and success for all will depend on their ability to navigate an increasingly unpredictable regulatory environment.

Staffing cuts, the politicization of regulatory decisions, and an expanded mission that now includes advancing policies not directly tied to patient benefit have disrupted long-standing norms...