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          Reporting Amount of Listed Drugs and Biological Products Technical Conformance GuideSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
					Guidance for Industry
		
		October 2021


	Download the  Final Guidance Document 

    Final
		
		    		Level 2 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2017-D-6821
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Center for Veterinary Medicine


FDA is issuing this Technical Conformance Guide (guide) to assist registrants of drug establishments (or their authorized agents) in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This guide supplements the draft guidance for industry Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (October 2021). The guide describes 1) how first-time users can access FDA’s CDER NextGen Portal (the portal) to submit these reports, 2) the different methods for submitting the reports through the portal, and 3) the data elements to be included in the reports.


 
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						All written comments should be identified with this document's docket number: FDA-2017-D-6821.

                                                                                  Content current as of:
      10/29/2021
         
                  
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