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          Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
					Guidance for Industry
		
		December 2020


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2019-D-3679
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Drug Evaluation and Research


This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial design (CID) proposals for drugs or biological products.   FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the 21st Century Cures Act (Cures Act).  In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review.  Additional recommendations related to the mandate set forth in section 3021 of the Cures Act are addressed in FDA’s guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics (Ref. 1).   This guidance finalizes the draft guidance of the same title dated September 2019.


 
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						All written comments should be identified with this document's docket number: FDA-2019-D-3679.



  
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                                                                                  Content current as of:
      01/22/2021
         
                  
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