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Zdrowie i gospodarka · 18/10/2024

FDA Releases Guidance on Long-Term Safety Studies for Neonatal Products

The US Food and Drug Administration (FDA) has released a final guidance for industry on long-term clinical neurodevelopmental safety studies for neonatal product development, aiming to ensure the safety of medical products for newborns. The guidance provides a framework for evaluating potential long-term effects of medical products on neonates' neurologic, sensory, and developmental health.

Source: Federal Register — Food and Drug AdministrationOpen original release →