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          Master Protocols for Drug and Biological Product DevelopmentSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Master Protocols for Drug and Biological Product Development
					
		
		December 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  	    This guidance is being distributed for comment purposes only.
	  
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    Print**Submit Comments by** 02/22/2024
	  	Submit Comments Online
			Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. 
				If unable to submit comments online, please mail written comments to:
				Dockets Management
				 Food and Drug Administration 
				 5630 Fishers Lane, Rm 1061 
				 Rockville, MD 20852
				 All written comments should be identified with this document's docket number: FDA-2023-D-5259
	Docket Number:
		    FDA-2023-D-5259
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


Additional Guidance Resources

Master Protocols: Guidance Snapshot
	Master Protocols: Guidance Recap Podcast
	Master Protocols: Podcast Transcript


This guidance document provides recommendations on the design and analysis of trials 16 conducted under a master protocol as well as guidance on the submission of documentation to 17 support regulatory review.

                                                                                  Content current as of:
      12/21/2023
         
                  
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