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          Human Gene Therapy Products Incorporating Human Genome EditingSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Human Gene Therapy Products Incorporating Human Genome Editing
					
		
		January 2024


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2021-D-0398
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research


In this guidance, we, FDA, are providing recommendations to sponsors developing human gene therapy  products incorporating genome editing (GE) of human somatic cells.  Specifically, this guidance provides recommendations regarding information that should be provided in an Investigational New Drug (IND) application in order to assess the safety and quality of the investigational GE product, as required in Title 21 of the Code of Federal Regulations 312.23 (21 CFR 312.23).  This includes information on product design, product manufacturing and testing, nonclinical safety assessment, and clinical trial design.


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-0398.



  
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                                                                                  Content current as of:
      01/30/2024
         
                  
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