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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry." This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting a determination of safety of an FDA-regulated "medical product" (i.e., drug, biological product, or medical device) for use in neonates. Although short-term safety evaluations may be appropriate for adults or other populations, such evaluations may not identify important adverse events in the neonatal population, as medical treatment during the neonatal period coincides with a time of critical growth and physiologic development and latent effects may not be evident until later in life following early-life exposures. Consideration of the potential for long-term neurologic, sensory, and developmental effects in the neonatal population early in a development program is important for establishing safety of a medical product intended for use in neonates. This guidance finalizes the draft guidance of the same title issued on February 13, 2023.

Abstract as published in the Federal Register.