Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development." This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and/or developmental evaluations could be useful in supporting a determination of safety of a regulated product for use in neonates, and which domains of assessment may be most pertinent. Although short-term safety evaluations may be acceptable for adults or other populations, such short-term evaluations may not identify important adverse events in the neonatal population, as latent effects may follow early-life exposures and drug treatment during the neonatal period coincides with a time of critical growth and physiologic development. Consideration of these potential long-term neurologic, sensory, and development effects in the neonatal population early in a drug development program will help ensure a safer product.