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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.

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