FDA Offers Biomarker Qualification Case Studies
By Zachary Brennan -
Published 14 June 2017
As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.
Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development
Tags: biomarker qualification, FDA case studies, biomarkers, drug development