Moving Biomarkers To General Acceptance: CDER's Pathway For Biomarker Qualification
Executive Summary
With the review of the PSTC's nephrotoxicity biomarker submission, CDER is testing out its pilot pathway for qualifying specific biomarkers for specific applications. Once qualified, a biomarker "would be accepted across all clinical divisions of FDA," Federico Goodsaid of CDER's Office of Translational Sciences noted at the DIA annual meeting in Atlanta.