A bill to modernize the process of accelerated approval of a drug for a serious or life-threatening disease or condition.
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.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)
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