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BioPharmaceutical Medical Device United States

Biomarkers: FDA Working To Define 'Reasonably Likely To Predict' Standard

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Executive Summary

CDER Director Woodcock says agency should write down its definition of a surrogate endpoint, but industry and academics will have to help with requirements for biomarker approval.

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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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