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          Investigational New Drug Applications Prepared and Submitted by Sponsor-InvestigatorsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
					
		
		May 2015


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2015-D-1484
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


The purpose of this guidance is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations.


 
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						All written comments should be identified with this document's docket number: FDA-2015-D-1484.

                                                                                  Content current as of:
      08/24/2018
         
                  
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