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# Neurodevelopmental Safety Studies in Neonatal Products
- URL: https://www.fdaweb.com/neurodevelopmental-safety-studies-in-neonatal-products/
- Published: 2024-10-17T12:00:00.000Z
- Updated: 2026-09-14T14:44:18.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5157998

FDA has published a guidance, *Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development*, with a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful to support a determination of the safety of a drug, biological product, or medical device for use in neonates, and which domains of neurodevelopment may be most applicable. The [document](https://www.fda.gov/media/165239/download?ref=fdaweb.com) does not specifically address effectiveness, safety, or benefit/risk assessments for products primarily intended to improve neurologic outcomes, such as neuroprotective agents, FDA says.

Rather, it says, the guidance is focused on long-term evaluations of neurodevelopmental safety. It does not focus on nonclinical safety studies to support clinical studies in neonates, and does not address clinical study design in neonatology. It also does not address neonatal or pediatric safety assessments following studies conducted during pregnancy, nor gene therapies or similar genomic medicine interventions.