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          Clarification of Orphan Designation of Drugs and  Biologics for Pediatric Subpopulations of Common DiseasesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Clarification of Orphan Designation of Drugs and  Biologics for Pediatric Subpopulations of Common Diseases
					Guidance for Industry
		
		December 2017


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2017-D-6380.
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of the Commissioner, Office of Clinical Policy and Programs, Office of Orphan Products Development


This guidance is intended for sponsors of drugs and biological products (hereafter drugs1) who are considering submitting requests for orphan-drug designation for their drugs under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The Food and Drug Administration (FDA) does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). Pediatric-subpopulation designations that have already been granted will not be affected by this change.

Additional copies are available from:
Office of Orphan Products Development
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 32, Rm. 5295
Silver Spring, MD 20993
Tel: 301-796-8660; E-mail: orphan@fda.hhs.gov
https://www.fda.gov/orphan


 
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						All written comments should be identified with this document's docket number: FDA-2017-D-6380..

                                                                                  Content current as of:
      07/27/2018
         
                  
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