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S. 4446

Modernizing the Accelerated Approval Pathway Act of 2022

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.

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

Sen. Collins, Susan M. [R-ME](R-ME)Sponsor
1 cosponsor1 D
1cosponsors1committees2actions1related bills
  1. IntroReferral

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

    Health, Education, Labor, and Pensions Committee
  2. IntroReferral10000

    Introduced in Senate

Modernizing the Accelerated Approval Pathway Act of 2022 — Informed