The bill S. 4426, known as the "Promising Pathway Act 2.0," proposes changes to the Federal Food, Drug, and Cosmetic Act. It introduces a temporary conditional approval pathway for certain drugs and biological products that treat rare, progressive, or serious diseases. This...
Simple Explanation
The Promising Pathway Act 2.0 is a plan to let some important new medicines for serious diseases become available to people sooner, even though doctors and scientists are still studying them. However, it also wants to make sure that these medicines are safe by making medicine makers check how well they work and keep patients informed.