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          Postapproval Changes to Drug Substances Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Postapproval Changes to Drug Substances Guidance for Industry
					
		
		September 2018


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2018-D-3151
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Center for Veterinary Medicine


This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs) and holders of drug master files (DMFs) and veterinary master files (VMFs) who want to make a change to the drug substance manufacturing process during the drug product application’s postapproval period.It does not address holders of biologics license applications (BLAs) or holders of any master files cross-referenced in BLAs.


 
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						All written comments should be identified with this document's docket number: FDA-2018-D-3151.

                                                                                  Content current as of:
      09/10/2018
         
                  
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