Workshop on Pediatric Safety Studies

Federal Register Notice: FDA’s Office of Pediatric Therapeutics and CDER are announcing a two-day public workshop 4/13-14 entitled “Advancing the Development of Pediatric Therapeutics: Successes and Challenges of Performing Long-Term Pediatric Safety Studies.” Its purpose is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies. Day 1 of the public workshop will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 will focus on suggestions for the future on study design and implementation of long-term safety studies in children. Viewpoints of patient representatives of children with chronic conditions and industry will be included. The workshop will be held from 8 a.m. to 5 p.m. at The DoubleTree by Hilton Hotel--Bethesda, 8120 Wisconsin Ave., Bethesda, MD. Contact Renan A. Bonnel, (301) 796-8654. To view this notice, click here.