S. 4446
Referred to CommitteeModernizing the Accelerated Approval Pathway Act of 2022
Latest Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)
6/22/2022 • Senate
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.
Introduced in Senate • 6/22/2022
Topics & Subjects
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Sponsor & Cosponsors (2)
Party Breakdown
Sponsor
Cosponsors (1)
Bill Journey
Originated in the Senate
Introduced
June 22, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)
Committee Review
Floor Debate
Passed Chamber
Other Chamber
President
Enacted into Law