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  3. Medical products for rare diseases and conditions
  4. Designating an Orphan Product: Drugs and Biological Products
  5. Orphan Drug Designation Request Form
  1. Designating an Orphan Product: Drugs and Biological Products

Orphan Drug Designation Request Form

The 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:

  1. Through the CDER NextGen portal
  2. By emailing the required information to orphan@fda.hhs.gov
  3. 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 20993-0002

See the webinar or refer to the webinar slides and script for more information about creating an orphan drug designation request. 

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