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          Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and AnswersSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
					Guidance for Industry and Review Staff
		
		June 2018


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2016-D-1307
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research
          Office of the Commissioner


This guidance provides answers to common questions regarding firms’ communication of health care economic information (HCEI) regarding their prescription drugs and medical devices to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors).  This guidance also addresses common questions relating to dissemination to payors of information about medical products that are not yet approved or cleared for any use and dissemination to payors of information about unapproved uses of approved/cleared medical products.


 
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						All written comments should be identified with this document's docket number: FDA-2016-D-1307.

                                                                                  Content current as of:
      09/30/2021
         
                  
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