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          Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry 
					
		
		July 2019


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2019-D-1768
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Veterinary Medicine


This guidance assists applicants and drug master file (MF) holders in the initiation of either revisions to an existing monograph(s) or development of a new monograph(s) under the United States Pharmacopeial Convention Pending Monograph Process (USP-PMP) during FDA’s evaluation of a drug master file or drug product application.2 This guidance describes the process that allows for the revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.


 
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						All written comments should be identified with this document's docket number: FDA-2019-D-1768.

                                                                                  Content current as of:
      07/10/2019
         
                  
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