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No More Biomarker Fumbling; Time to Get Serious

This article was originally published in Scrip

Executive Summary

Developing reliable, informative biomarkers has been a messy business over the past two decades, said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), who acknowledged there's been a lot of "fumbling" in determining what types of evidence are needed, because of uncertainty by regulators and a lack of research funding.






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