HR 9938
Promising Pathway Act 2.0
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- Passed House
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- Became Law
Bill overview
The Promising Pathway Act 2.0 creates a faster approval process for certain drugs and biological products intended to treat rare, progressive, and serious diseases. It allows the Secretary of the Food and Drug Administration (FDA) to grant ‘conditional approval’ based on preliminary clinical data, prioritizing review and offering benefits similar to full approval. The bill also establishes an observational registry requirement to gather ongoing safety data and includes provisions for renewal and eventual transition to standard approval, while limiting liability for sponsors and providers.
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Primary sponsor
Cosponsor
Mike Garcia
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