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

07 Sep 2015
News

Derrick Gingery @dgingery derrick.gingery@informa.com

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

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