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          Individual Patient Expanded Access Applications: Form FDA 3926Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Individual Patient Expanded Access Applications: Form FDA 3926
					
		
		October 2017


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2015-D-0268
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


This guidance describes From FDA 39262(Individual Patient Expanded Access - Investigational New Drug Application (IND)), which is available for licensed physicians to use for expanded access requests for individual patient INDs. The terms *compassionate use* and *preapproval access* are also occasional used in the context of the use of an investigational drug to treat a patient; however, these terms are not defined or described in FDA regulations. Individual patient expanded access allows for the sue of an investigational new drug3outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy for submitting an IND under 21 312.23 for use in cases of individual patient expanded access, including for emergency use. This guidance and Form FDA 3926 do not apply to other types of expanded access requests, including request for expanded access for medical devices.

OMB Control Number:  0910-0814

Expiration Date:  06/30/2025


 
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						All written comments should be identified with this document's docket number: FDA-2015-D-0268.

                                                                                  Content current as of:
      01/29/2024
         
                  
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