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          Rare Pediatric Disease Priority Review VouchersSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Rare Pediatric Disease Priority Review Vouchers
		 
			Draft Guidance for Industry
		
		July 2019


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2014-D-1461
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of the Commissioner, Office of Clinical Policy and Programs, Office of Orphan Products Development
          Center for Biologics Evaluation and Research


This guidance provides information on the implementation of section 908 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which added section 529 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Under section 529, FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word *should*in Agency guidances means that something is suggested or recommended, but not required.


 
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						All written comments should be identified with this document's docket number: FDA-2014-D-1461.

                                                                                  Content current as of:
      04/15/2020
         
                  
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