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          Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product DevelopmentSearch for FDA Guidance Documents 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			Draft Guidance for Industry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	Download the  Draft  Guidance Document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	  	    Not for implementation.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.
	  
	  
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    PrintDocket 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.


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

                                                                                  Content current as of:
      02/10/2023
         
                  
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