Federal Register Notice: FDA is announcing a public workshop 12/12 entitled “Developing and Using Precision Therapies in the ‘Omics’ Era: Generating and Interpreting Evidence for Rare Subsets.” The workshop is being co-sponsored with the Center for Translational and Regulatory Sciences at the University of Virginia. The goals are to facilitate discussion on current scientific approaches using rare subsets during drug development programs and to further seek input from multiple stakeholders on approaches to obtain evidence that inform the regulatory evaluation of therapeutic products in rare subsets of patients identified through in-vitro diagnostic testing when specific, controlled trials are not feasible. workshop will be held, from 9 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD. Contact Padmaja Mummaneni, (301) 796-2027, email: padmaja.mummaneni@fda.hhs.gov. To view this notice, click here.