FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development
FDA Law Blog: Biosimilars
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”). The Guidance is written carefully to communicate that these determinations are all very case-specific. What does it all mean?
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