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          ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
					
		
		December 2022


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2017-D-3101
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research, Office of Pharmaceutical Quality


The Food and Drug Administration (FDA) is issuing this revised draft guidance to incorporate program enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC)2 within the abbreviated new drug application (ANDA) assessment program3 agreed upon by the Agency and industry as part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA III), as described in *GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027* (GDUFA III commitment letter).4This guidance replaces the November 2017 draft guidance for industry on *ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence)*.5


 
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						All written comments should be identified with this document's docket number: FDA-2017-D-3101.

                                                                                  Content current as of:
      12/02/2022
         
                  
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