S 4446
Modernizing the Accelerated Approval Pathway Act of 2022
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- Passed House
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Bill overview
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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