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          Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and AnswersSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
					Guidance for Industry
		
		May 2023


	Download the  Final Guidance Document
	    
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		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2021-D-1268
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
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This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology  peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology  studies using non-human specimens.2 When whole slide imaging is used as part of a nonclinical 20 study conducted in compliance with the GLP regulations, adequate documentation is critical. The  FDA’s expectations regarding documentation practices during generation, use, and retention of  whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA’s recommendations concerning  the management, documentation, and use of whole slide imaging in histopathology assessment  and/or pathology peer review for nonclinical studies conducted in compliance with the GLP  regulations.


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-1268.

                                                                                  Content current as of:
      05/24/2023
         
                  
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