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          Tobacco Product Master FilesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Tobacco Product Master Files
					Guidance for Industry
		
		May 2016


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2015-D-2325
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Tobacco Products


This guidance provides recommendations to industry on tobacco product master files (TPMFs). TPMFs are used to permit the person that owns the TPMF (TPMF owner) to authorize other persons to rely on information in the TPMF to support a submission to FDA without the TPMF owner having to disclose that information to other persons. These files typically contain trade secret and/or confidential commercial information that the TPMF owner does not wish to make public.


 
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						All written comments should be identified with this document's docket number: FDA-2015-D-2325.



  
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                                                                                  Content current as of:
      02/13/2020
         
                  
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