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          Evaluation of Therapeutic EquivalenceSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Evaluation of Therapeutic Equivalence
					
		
		July 2022


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2022-D-0528
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


The draft guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what the TE codes indicate. The guidance explains how FDA evaluates drug products for, and determines TE for, multi-source drug products to be listed in the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). The guidance provides background on the fundamentals of TE and utilizes a question and answer format to provide more information on the therapeutic equivalence evaluation of approved drug products and assignment of TE codes in the Orange Book.


 
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						All written comments should be identified with this document's docket number: FDA-2022-D-0528.

                                                                                  Content current as of:
      01/11/2023
         
                  
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