FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development
FDA Law Blog
OCTOBER 28, 2024
The protocol should also include a plan for clinical referral and support services if any developmental problems are identified during the follow-up. Additionally, the Guidance states that sponsors should provide study plans for FDA review. Patient/population-specific considerations include the timing and frequency of assessments.
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