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          Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
		 
			Draft Guidance for Industry
		
		September 2021


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2020-D-2307
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Oncology Center of Excellence


The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this section, FDA created a framework for a program to evaluate the potential use of real-world evidence (RWE) to help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help to support or satisfy postapproval study requirements (RWE Program).


 
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						All written comments should be identified with this document's docket number: FDA-2020-D-2307.

                                                                                  Content current as of:
      12/10/2021
         
                  
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