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          Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry
					Guidance for Industry
		
		June 2023


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2020-D-1480
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Drug Evaluation and Research


The purpose of this guidance is to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach.

For this guidance, a therapeutic protein refers to a protein that is being developed for licensure, or is licensed, as a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262). Therapeutic proteins include purified monoclonal antibodies, cytokines, enzymes, and other novel proteins for in vivo use. Therapeutic proteins do not include proteins intended to act as vaccines or allergenic products, cellular and gene therapy products, and/or human cells, tissues, and cellular and tissue-based products.5 Although this guidance applies to therapeutic proteins, many of the general principles may be applicable to other biological products, such as novel products regulated by CBER (e.g., cellular and gene therapies).


 
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						All written comments should be identified with this document's docket number: FDA-2020-D-1480.

                                                                                  Content current as of:
      06/02/2023
         
                  
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