Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification; Public Workshop

The Food and Drug Administration (FDA), in co-sponsorship with the Foundation for the National Institutes of Health Biomarkers Consortium (FNIH BC), is announcing a public workshop entitled ``Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.'' The purpose of the workshop is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on drug safety markers. The 2-day workshop will focus on the standards relevant to the qualification of a range of safety biomarkers and examine case studies in several different organ systems.