Crossing the Valley of Death, Part 2: FDA Reform

Source: Hoover Institution
by Ted Cho & Brian Miller

“The second of two policy briefs exploring the ‘valley of death’ between FDA approval and Medicare coverage, this brief focuses on improving FDA processes to expand access to innovation. It explores three key reforms: product reviewer job redesign through the use of AI to support clinical and scientific evaluation; regulator-prompted clinical trial reform; and center-level organizational restructuring to expand the frontline workforce while reducing administrative overhead.” (08/08/25)

https://www.hoover.org/research/crossing-valley-death-part-2-fda-reform