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          Pathology Peer Review in Nonclinical Toxicology Studies: Questions and AnswersSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
					
		
		December 2021


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2019-D-2330
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Veterinary Medicine
          Center for Devices and Radiological Health
          Center for Food Safety and Applied Nutrition
          Center for Drug Evaluation and Research


This guidance provides information to sponsors and nonclinical laboratory staff regarding the management and conduct of pathology peer review performed during good laboratory practice (GLP)-compliant toxicology studies. When conducted, pathology peer review should be well-documented. However, documentation practices during pathology peer review 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, conduct, and documentation of pathology peer review.


 
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						All written comments should be identified with this document's docket number: FDA-2019-D-2330.

                                                                                  Content current as of:
      01/05/2022
         
                  
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