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# Guide on Neonatal Neurodevelopmental Safety
- URL: https://www.fdaweb.com/guide-on-neonatal-neurodevelopmental-safety/
- Published: 2023-02-14T12:00:00.000Z
- Updated: 2026-09-14T18:15:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153770

*Federal Register* notice: FDA has made available a draft guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.” The document provides a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting a safety determination for such products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-02-13/pdf/2023-02962.pdf?ref=fdaweb.com).