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          Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry
					
		
		April 2022


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2017-D-0759
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


Nanotechnology can be used in a broad array of FDA-regulated products, such as human **drug products**, including those that are **biological products**.3 Nanotechnology may be used to create drug products in which **nanomaterials** (as explained in section II of this document), serve a variety of functions, as active ingredients4 or **inactive ingredients**, including **carriers** loaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form.


 
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						All written comments should be identified with this document's docket number: FDA-2017-D-0759.

                                                                                  Content current as of:
      04/20/2022
         
                  
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