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          Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
					
		
		September 2022


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2019-D-1263
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data (RWD) and real-world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. This guidance does not address FDA’s substantive review of the RWD/RWE submitted as part of the Agency’s standard review process.

This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) that contain RWD/RWE intended to support a regulatory decision regarding product safety and/or effectiveness.


 
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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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						Dockets Management
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						All written comments should be identified with this document's docket number: FDA-2019-D-1263.

                                                                                  Content current as of:
      09/08/2022
         
                  
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