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          Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and FormatSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format
					
		
		July 2022


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2019-D-1615
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research


This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA).


 
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						All written comments should be identified with this document's docket number: FDA-2019-D-1615.

                                                                                  Content current as of:
      07/14/2022
         
                  
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