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          CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal DrugsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
					
		
		October 2021


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2020-D-1400
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine


This guidance describes how CVM intends to evaluate real-world data and real-world evidence in submissions to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug.  It also provides information about how sponsors may obtain feedback from CVM on technical issues related to the use of real-world data and real-world evidence before the submission of an application.


 
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						All written comments should be identified with this document's docket number: FDA-2020-D-1400.



  
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                                                                                  Content current as of:
      10/05/2021
         
                  
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				     				  				     Target Animal – EffectivenessSearch for FDA Guidance Documents

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