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.
| Action Date | Type | Text | Source |
|---|---|---|---|
| 2022-06-22 | IntroReferral | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078) | Senate |
| 2022-06-22 | IntroReferral | Introduced in Senate | Library of Congress |