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          Meetings with the Office of Orphan Products DevelopmentSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Meetings with the Office of Orphan Products Development
					Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff
		
		July 2015


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2014-D-0313
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of the Commissioner, Office of Clinical Policy and Programs, Office of Orphan Products Development


This guidance provides recommendations to industry, researchers, patient groups, and other stakeholders (collectively referred to in this guidance as “stakeholders”) interested in requesting a meeting, including a teleconference, with the Food and Drug Administration’s (FDA’s) Office of Orphan Products Development (OOPD) on issues related to orphan-drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product1 patient-related topics of concern. It is also intended to assist OOPD staff in addressing such meeting requests. This guidance describes procedures for requesting, preparing, scheduling, conducting, and documenting such meetings.


 
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						All written comments should be identified with this document's docket number: FDA-2014-D-0313.

                                                                                  Content current as of:
      07/12/2018
         
                  
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