Modernizing the Accelerated Approval Pathway Act of 2022

Hozzl · 2022-12-29T17:48:34Z

Explore the details of Senate Bill 4446 Modernizing the Accelerated Approval Pathway Act of 2022 currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

12/29/2022, 5:48 PM

Congressional Summary of S 4446

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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Current Status of Bill S 4446

Bill S 4446 is currently in the status of Bill Introduced since June 22, 2022. Bill S 4446 was introduced during Congress 117 and was introduced to the Senate on June 22, 2022. Bill S 4446's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078) as of June 22, 2022