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.