Search Results for keywords:"observational registries"

Search Results: keywords:"observational registries"

S. 4426 — To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes.
May 23, 2024
Status:Introduced in Senate
Congress:118
Words:5,340
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.
H. R. 9938 — To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes.
October 04, 2024
Status:Introduced in House
Congress:118
Words:5,297
H. R. 9938 proposes amendments to the Federal Food, Drug, and Cosmetic Act to create a new, conditional approval pathway for certain drugs and biological products. This pathway is intended for drugs treating rare, progressive, and serious diseases, allowing them to receive...
Simple Explanation
H. R. 9938 is a plan to let special medicines for serious sicknesses be used sooner while they are still being checked. People who take these medicines might have to follow some rules, and health plans have to help pay for them.

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