United States · Bill · S
S. 4446 (117th)
Modernizing the Accelerated Approval Pathway Act of 2022
Introduced
22 June 2022
Last action
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Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)
Sponsors
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Subjects
Discovery layer
Source updated
21 April 2025
Summary
Modernizing the Accelerated Approval Pathway Act of 2022 This bill modifies provisions relating to the accelerated approval of drugs for serious or life-threatening diseases or conditions, including by requiring the Food and Drug Administration (FDA) to publish its reasons when it determines a postapproval study to be unnecessary. The bill also establishes a pilot program and an FDA council to support the development of drugs for rare diseases and ensure the appropriate use of the accelerated approval pathway, respectively.
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate (text)
Introduced in Senate · EN · 22 June 2022
Introduced in Senate (PDF)
Introduced in Senate · EN · 22 June 2022
Introduced in Senate
summary · EN · 22 June 2022
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Sources
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- Official source: https://www.congress.gov/bill/117th-congress/senate-bill/4446
- Open data entity: https://api.congress.gov/v3/bill/117/s/4446