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          Benefit-Risk Considerations for Product Quality AssessmentsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Benefit-Risk Considerations for Product Quality Assessments
					
		
		May 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	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2022-D-0168
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA assessment as part of original new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), original biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act), or supplements to such applications, in addition to other information (e.g., inspectional findings) available to FDA during its assessment.


 
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						All written comments should be identified with this document's docket number: FDA-2022-D-0168.

                                                                                  Content current as of:
      05/10/2022
         
                  
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