By Lauren Martz, Staff Writer
The FDA's push for
Despite the huge output of preclinical papers on new
biomarkers, few result in validated agents that contribute to clinical trials.
The FDA turned to stakeholders from
industry and academia last week to discuss the challenges in the space and hear
proposals for how to address them. Meeting attendees agreed that clarity and
standardization of the regulatory process involving biomarkers is critical for
advancing the use of biomarkers.