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          Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General ConsiderationsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
					
		
		March 2014


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2014-D-0204
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations” (draft BA and BE guidance for NDAs). The draft guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises those parts of the March 2003 guidance entitled “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations” relating to BA and BE studies for INDs, NDAs, and NDA supplements.


 
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						All written comments should be identified with this document's docket number: FDA-2014-D-0204.

                                                                                  Content current as of:
      04/29/2020
         
                  
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