April 27, 2023
ASA Recommends Neurodevelopmental Safety Considerations for Neonatal Product Development
This week, the American Society of Anesthesiologists (ASA) submitted comments to the Food and Drug Administration (FDA) on the agency’s Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Draft Guidance for Industry. Drawing from the expertise of ASA’s pediatric anesthesiologists, the comment letter highlighted the critical balance of enabling industry stakeholders to develop new drugs and medical products while providing safeguards to protect the neonatal patients who participate in studies and clinical trials.
ASA requested that FDA address acute impairment from neonatal drugs and products on the cardiovascular, renal, hepatic, and musculoskeletal systems, as these impairments can have subsequent effects on a child’s neurodevelopment. ASA’s comments also suggested a new section within the guidance on product delivery considerations and recommended extending the timing for long-term developmental studies beyond two years, as some measures of neurologic development cannot be assessed until a patient is in late childhood or early adolescence.
Click here to read ASA’s full comment letter.
Please contact the ASA Department of Quality and Regulatory Affairs at [email protected] with any questions.