Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Draft Guidance for Industry
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Clinical - Medical, Pediatric Product Development
Published
February 10, 2023
Last updated
July 23, 2024
Description
Draft guidance document for industry on conducting long-term clinical neurodevelopmental safety studies in neonatal product development.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)