FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development
FDA Law
OCTOBER 28, 2024
To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). When a comprehensive neurodevelopmental evaluation is needed, it should include an evaluation of physical, mental, and social health.
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