Workshop on Extrapolating Data for Pediatric Efficacy

Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 6/1 entitled “Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.” The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. It will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions. It will take place from 8 a.m. to 5 p.m. at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Audrey Thomas, (301) 796-3520, Audrey.Thomas@fda.hhs.gov. To view this notice, click here.