Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Medical products for rare diseases and conditions

Rare Pediatric Disease (RPD) Designation and Voucher Programs Home
          For Industry
          Medical products for rare diseases and conditions
          Rare Pediatric Disease (RPD) Designation and Voucher ProgramsMedical products for rare diseases and conditions Rare Pediatric Disease (RPD) Designation and Voucher Programs
  	
        Share
    Post
    Linkedin

    Email
    PrintUnder Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

**RPD Designation Program Sunset Provisions**

On December 27, 2020, the Rare Pediatric Disease Priority Review Voucher Program was extended. Under the current statutory sunset provisions, after September 30, 2024, FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has rare pediatric disease designation for the drug, and that designation was granted by September 30, 2024. After September 30, 2026, FDA may not award any rare pediatric disease priority review vouchers.

For any questions, please contact the Office of Orphan Products Development at orphan@fda.hhs.gov.


**On July 29, 2019, FDA issued a revised draft guidance,**Rare Pediatric Disease Priority Review Vouchers - Guidance for Industry.

The revised draft guidance incorporates public comments received on the initial draft and provides FDA’s thinking regarding the provisions of the Advancing Hope Act of 2016, which updated the definition of a rare pediatric disease as one that is a rare disease and one where the disease is serious or life-threatening with the serious or life-threatening manifestations primarily affecting individuals from age zero to 18. Among the key changes from the initial draft are an explanation of the rare pediatric disease priority review voucher eligibility requirements, the rare pediatric disease designation process and examples to illustrate the agency’s current thinking on these review determinations.


Contact Information

Questions about the RPD designation program, contact the Office of Orphan Products and Development (OOPD):

orphan@fda.hhs.gov or 301-796-8660

Questions about drug products, RPD PRV eligibility, contact the Center for Drug Evaluation and Research (CDER):

PriorityReviewVouchers@fda.hhs.gov or 301-796-1394

Questions about biologic products, RPD PRV eligibility, contact the Center for Biologics Evaluation and Research (CBER):

industry.biologics@fda.hhs.gov or 240-402-8020

When sponsors use a priority review voucher to obtain a priority review of a drug application, they are required to pay a fee in order to do so.  The Federal Register notice concerning the fee for redeeming a Rare Disease Priority Review Voucher in fiscal year 2017 program is available here: https://www.gpo.gov/fdsys/pkg/FR-2016-09-30/pdf/2016-23624.pdf

Section 529 of the FD&C Act is codified at 21 U.S.C. 360ff.  the full text is available at: https://www.gpo.gov/fdsys/pkg/USCODE-2012-title21/pdf/USCODE-2012-title21-chap9-subchapV-partB-sec360ff.pdf (please note that this version does not contain the advancing Hope Act of 2016 amendments).

**Request for Rare Pediatric Disease designation should be sent to orphan@fda.hhs.gov or by mail to:**

Office of Orphan Products Development 
Food and Drug Administration
WO32-5295
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002

Sponsors and others who plan to email information to FDA that is private, sensitive, proprietary or commercial confidential are strongly encouraged to send it from an FDA-secured email address so the transmission is encrypted. The agency will assume the addresses of emails received or email addresses provided as a point of contact are secure when responding to those email addresses. Sponsors and others can establish a secure email address link to FDA by sending a request to SecureEmail@fda.hhs.gov. There may be a fee to a commercial enterprise for establishing a digital certificate before encrypted emails can be sent to FDA.

                                                                                  Content current as of:
      12/15/2023Rare Pediatric Disease (RPD) Designation and Voucher Programs
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop