Pediatric Cancer: US FDA May Invite European Regulators To Observe ‘Type F’ Meetings With Sponsors
Executive Summary
Early advice meetings allow sponsors to hear the FDA’s current thinking about relevance of a specific molecular target and expectations for early assessment of an adult cancer drug in children unless a waiver or deferral is justified; agency has waived subsequent pediatric studies for some same-in-class products, including PD-1/L1 inhibitors.