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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
          Orphan Drug Designation Request FormDesignating an Orphan Product: Drugs and Biological Products Orphan Drug Designation Request Form
  
  	
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    PrintThe Form FDA 4035 is designed to assist sponsors in providing the required content completely and succinctly for orphan drug designation requests. If you receive a “Please wait ...” message when you click on the Form FDA 4035, go to the upper right download arrow and download the form. Adobe Acrobat XI Pro, or equivalent, is recommended.

Sponsors may submit orphan drug designation requests one of three ways:

Through the CDER NextGen portal
	By emailing the required information to orphan@fda.hhs.gov
	By mailing the required information to:
	Office of Orphan Products Development
	Attention: Orphan Drug [or Rare Pediatric Disease] Designation Program
	Food and Drug Administration
	WO32-5295
	10903 New Hampshire Avenue
	Silver Spring, MD 20993-0002See the webinar or refer to the webinar slides and script for more information about creating an orphan drug designation request.

                                                                                  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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