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

 
• By Derrick Gingery

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.

FDA wants to help expand biomarker use as surrogate endpoints, but is encouraging pharma companies and researchers to create common evidentiary standards and vocabulary for their development.

Agency officials plan to look at potentially publishing their definition of the “reasonably likely to predict clinical benefit” standard for a surrogate endpoint to be used for accelerated approval, said...

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More from North America

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