Animal Models: Adcomm Exposes Internal Rift In How FDA Defines ‘Translational’ For Purposes Of Confirmatory Evidence

12 Oct 2023

FDA review staff consider the animal models used in development of US WorldMeds’ eflornithine for neuroblastoma to be translational to humans, even though this does not align with the definition in a September 2023 draft guidance on types of confirmatory evidence.

Mouse in lab — The translatability of mouse models to humans was critical to ODAC's view on the acceptance of such data as confirmatory evidence. • Source: Shutterstock

Animal Models: Adcomm Exposes Internal Rift In How FDA Defines ‘Translational’ For Purposes Of Confirmatory Evidence

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