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Priority review
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Designation
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Reduces time of application review process from 10 to 6 months of priority regulatory review
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Breakthrough therapy
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Designation
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Expedites review of drugs that may show substantial improvement for patients with serious diseases over existing drugs
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Fast track
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Designation
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Expedites drug development and review to treat serious conditions and fill unmet medical need
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Accelerated approval
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Approval pathway
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Permits use of surrogate or intermediate clinical endpoint for filling an unmet medical need for serious conditions
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