As part of its Critical Path program to speed the movement of discoveries from bench to bedside, the US Food and Drug Administration has launched an initiative to bring biomarkers — including protein biomarkers — to the forefront of drug development, according to an agency official.
The FDA plans to issue guidelines to industry on what criteria are necessary in order for a biomarker to be used as a surrogate endpoint, and to promote the use of biomarkers systematically throughout the process of drug development.