Modernizing the Accelerated Approval Pathway Act of 2022

United States117th CongressS-4446Senate
Updated: Jun 22, 2022

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.

Bill texts

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Introduced (Senate)View official text

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Timeline

  1. Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)

    Senate

  2. Introduced in Senate

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