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          Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling DocumentationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
					
		
		April 2018


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2016-D-2817
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance discusses what types of information you, the applicant, should submit in your new drug application (NDA) or abbreviated new drug application (ANDA) for a liposome drug product reviewed by the Center for Drug Evaluation and Research (CDER). The discussion addresses the following topics for liposome drug products: (A) chemistry, manufacturing, and controls (CMC); (B) human pharmacokinetics and bioavailability or, in the case of an ANDA, bioequivalence; and (C) labeling in NDAs and ANDAs.


 
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						All written comments should be identified with this document's docket number: FDA-2016-D-2817.

                                                                                  Content current as of:
      10/04/2021
         
                  
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