Bill > S4446

This bill aims to modernize the process of accelerated approval of drugs for serious or life-threatening diseases or conditions. It makes several key changes to the accelerated approval pathway under the Federal Food, Drug, and Cosmetic Act, including: requiring the FDA to specify conditions for any post-approval studies, allowing studies to start before approval, providing expedited procedures for withdrawing accelerated approval, and requiring sponsors to submit periodic progress reports. The bill also directs the FDA to establish an intra-agency council to ensure consistent and appropriate use of accelerated approval, and to develop guidance and provide training for product review teams. Additionally, it establishes a pilot program to advance the development of efficacy endpoints, including surrogate and intermediate endpoints, for rare disease drug development.

Health and Social Services

https://www.congress.gov/bill/117th-congress/senate-bill/4446/all-info