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          Field Alert Report Submission: Questions and Answers Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Field Alert Report Submission: Questions and Answers Guidance for Industry
					Guidance for Industry
		
		July 2021


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2018-D-2326
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of Regulatory Affairs
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions.


 
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						All written comments should be identified with this document's docket number: FDA-2018-D-2326.

                                                                                  Content current as of:
      07/22/2021
         
                  
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