Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

10 February 2023 – the FDA published draft guidance on long-term clinical neurodevelopmental safety studies in neonatal product development.

The purpose of this guidance is to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device (referred to as ‘medical product’ in this guidance) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.

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