S 4446 · 117th Congress · Health
Modernizing the Accelerated Approval Pathway Act of 2022
Bill Progress
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Introduced2
Committee3
Senate Vote4
House5
EnactedLatest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)(2022-06-22)
Plain Language Summary
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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.…
Summarized by Claude AI · Non-partisan · For informational purposes only