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BioPharmaceutical United States Clinical Trials

Redefining Accelerated Approval Criteria Would Expand Pathway’s Use, Panel Says

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Executive Summary

Expanding the definition of “unmet medical need” and adopting a narrow, molecularly targeted approach to determining the existence of “available therapies” would enable use of the approval pathway in earlier treatment settings, a group of stakeholders tells a cancer research conference.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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