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FDA Issues Final Guidance on Long-Term Neurodevelopmental Safety Studies in Medical Products for Newborns

Today, the U.S. Food and Drug Administration announced the final guidance, Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development. The guidance provides a framework for considering neurodevelopmental evaluations that could be useful to assess long-term safety of a medical product intended for use in newborns, and replaces draft guidance issued in February 2023 with the same name.

Treating newborns with medical products coincides with a time of critical growth and development. Short-term safety evaluations typical for adults or other populations may fail to identify important adverse effects in newborns, which may follow early-life exposures. Long-term safety studies are often important to assess the safety of medical products used in newborns because important health effects resulting from medical products used during the newborn period may not become apparent until after a baby has grown older.

For more information:

• Federal Register notice: Guidance: Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
• Guidance snapshot (PDF infographic featuring highlights of this guidance)
• Guidance recap podcast (audio, 12 minutes, discussing the draft guidance issued in Feb. 2023)
• Transcript of the guidance recap podcast

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