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  1. Designating an Orphan Product: Drugs and Biological Products

Corresponding with the OOPD Drug Designation Programs

Thank you for your interest in the OOPD designation program for Orphan Drugs or for Rare Pediatric Diseases. If you have an inquiry, a meeting request, and/or wish to send a document to an OOPD drug designation program, the information provided below is for your convenience and will help us to be more efficient in responding and assisting you.

Topic Telephone Email Mail
       
General information X X  

Request for a meeting

Note: Please see the Guidance for more information

  X  

Original or amended Orphan Drug or RPD request

Note: For amendments, please include updated contact information, if applicable.

    X
Change in contact/agent information   X  

Transfer/change in ownership of ODD or RPD

Note: Please see 21 CFR §316.27 for more information

  X  
Annual Report   X  

 

Please click on the contact methods below for additional information:

Contact Method

 

 

 

              

 

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