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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RO1) 

Receipt Date: June 25, 2019

FOA Number: RFA-FD-20-001

 

Funding Opportunity Purpose:

The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis. Through the support of efficient and innovative clinical studies evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients.