About FDA

What is the role of FDA's Office of Orphan Product Development and Office of New Drugs?

Nearly 30 million individuals are affected by rare diseases in the United States. A disease is considered rare if it affects fewer than 200,000 within the United States and there are more than 7000 such diseases and conditions. Rare diseases in childhood can be debilitating and require lifelong care. FDA’s Office of Orphan Product Development and Office of New Drugs facilitate the development and improve availability of treatment products for all patients including children with rare diseases.

Here are the resources to help you to find out more about orphan drug development:


Page Last Updated: 09/19/2017
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