FDA Public Workshop on Evidentiary Standards Framework for Safety Biomarkers
The U.S. Food and Drug Administration, in cosponsorship with the Foundation for the National Institutes of Health Biomarkers Consortium, 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. DATES: The public workshop will be held on April 14, 2016, from 9 a.m. to 5 p.m. and April 15, 2016, from 8 a.m. to 5 p.m. The public workshop will be held at the Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852.