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GUIDANCE DOCUMENT

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development Draft Guidance for Industry February 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0112
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics
Center for Drug Evaluation and Research

The purpose of this guidance is to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device (referred to as ‘medical product’ in this guidance) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.

This guidance will not specifically address efficacy or effectiveness assessments for products primarily intended to improve neurologic outcomes, e.g., neuroprotective agents. This guidance is focused on long-term evaluations of neurodevelopmental safety. Although assessments of nephrotoxicity, pulmonary toxicity, and toxicity to other tissues and organs may also be warranted in neonatal medical product development, the approach to those assessments is outside the scope of this guidance.

Additional Guidance Resources

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All written comments should be identified with this document's docket number: FDA-2022-D-0112.

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