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          Translation of Good Laboratory Practice Study Reports: Questions and AnswersSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Translation of Good Laboratory Practice Study Reports: Questions and Answers
					
		
		November 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  	    This guidance is being distributed for comment purposes only.
	  
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    Print**Submit Comments by** 02/20/2024
	  	Submit Comments Online
			Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. 
				If unable to submit comments online, please mail written comments to:
				Dockets Management
				 Food and Drug Administration 
				 5630 Fishers Lane, Rm 1061 
				 Rockville, MD 20852
				 All written comments should be identified with this document's docket number: FDA-2023-D-4719
	Docket Number:
		    FDA-2023-D-4719
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This FDA guidance provides information to sponsors and nonclinical laboratories regarding the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations (21 CFR part 58) submitted to FDA for review.

                                                                                  Content current as of:
      11/21/2023
         
                  
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