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          Drug Master Files Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Drug Master Files Guidance for Industry
					
		
		November 2019


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2019-D-3989
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance provides FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types of information as well (e.g., toxicology information, shared system REMS (risk evaluation and mitigation strategy)).


 
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						All written comments should be identified with this document's docket number: FDA-2019-D-3989.

                                                                                  Content current as of:
      11/19/2019
         
                  
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