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 In this section:

                Designating an Orphan Product: Drugs and Biological Products

Designating an Orphan Product: Drugs and Biological Products

                        Orphan Drug Designation Request Form
          Orphan Drug Act - Relevant Excerpts
          Frequently Asked Questions (FAQ) About Designating an Orphan Product
          Orphan Drug Designation: Disease Considerations
          Clinical Superiority Findings
          Instructions for Searchable Designation Database
          Public Identification of Orphan Drug Designation
          Improving the Prevention, Diagnosis, and Treatment of Rare and Neglected Diseases; FDA Report to Congress
          Contact Us Home
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          Medical products for rare diseases and conditions
          Designating an Orphan Product: Drugs and Biological Products
          Contact UsDesignating an Orphan Product: Drugs and Biological Products Contact Us
  
  	
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    PrintContacts for various questions, requests and submissions related to orphan products are included below.

General inquiries: 301-796-8660 or orphan@fda.hhs.gov

Contact orphan@fda.hhs.gov to:

Request a meeting
	Submit an orphan drug, rare pediatric disease or humanitarian use device designation request
	Submit changes to your contact information
	Transfer or change ownership of an orphan drug designation, rare pediatric disease designation or humanitarian use device designation
	Submit an annual reportSponsors 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.

See orphan drug designations for more information.

                                                                                  Content current as of:
      09/07/2021Designating an Orphan Product: Drugs and Biological Products

          
                        Orphan Drug Designation Request Form
          Orphan Drug Act - Relevant Excerpts
          Frequently Asked Questions (FAQ) About Designating an Orphan Product
          Orphan Drug Designation: Disease Considerations
          Clinical Superiority Findings
          Instructions for Searchable Designation Database
          Public Identification of Orphan Drug Designation
          Improving the Prevention, Diagnosis, and Treatment of Rare and Neglected Diseases; FDA Report to Congress
          Contact Us
 
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