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          Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local ActionSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
					
		
		April 2003


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-1999-D-0050
	    	    		    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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.” This draft document provides recommendations to applicants planning product quality studies to document bioavailability (BA) or bioequivalence (BE) in support of new drug applications (NDAs), or abbreviated new drug applications (ANDAs) for locally acting drugs in nasal aerosols (metered-dose inhalers) and nasal sprays (metered-dose spray pumps). The draft guidance was originally issued for comment on June 24, 1999. Since many substantive changes have been made to the guidance, it is being reissued for comment as a level 1 draft guidance.


 
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						All written comments should be identified with this document's docket number: FDA-1999-D-0050.

                                                                                  Content current as of:
      04/29/2020
         
                  
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