FDA and Triangle CERSI Announce Virtual Workshop on Pediatric Drug Development Safety and New Approach Methodologies

https://reg.learningstream.com/reg/event_page.aspx?ek=0087-0030-f8d67ef7bf954d1cad1374c8dc1bed56&utm_medium=email&utm_source=govdelivery On December 5, 2025, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology, in collaboration with the Triangle Center of Excellence in Regulatory Science and Innovation (CERSI), will hold a virtual workshop entitled “Pediatric Developmental Safety Assessment: New Approach Methods”. At this workshop, speakers and participants will: (1) gain an understanding of current programs in federal agencies related to novel alternative methods and pediatric developmental biology; (2) discuss the identification and utilization of secondary targets in a pediatric developmental safety assessment; (3) review the use of juvenile animal studies and in vitro tools to assess pediatric developmental safety assessment; and (4) explore the use of model-informed drug development techniques in pediatric developmental safety assessment. More information about this event can be found at the Pediatric Developmental Safety Assessment: New Approach Methods web page. https://www.fda.gov/drugs/news-events-human-drugs/pediatric-developmental-safety-assessment-new-approach-methods-12052025?utm_medium=email&utm_source=govdelivery