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  1. Developing Products for Rare Diseases & Conditions

Funding Opportunities

Upcoming Receipt Dates:

 

Clinical Trials

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

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Receipt Dates: October 6,2020, October 5, 2021

FOA Number: RFA-FD-21-001

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Funding Opportunity Purpose:

The purpose of this funding opportunity announcement (FOA) is to fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions. Through the funding of efficient and innovative clinical studies evaluating safety and/or efficacy, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and exert a broad and positive impact on rare disease drug development.

 

Natural History

Our current receipt date has closed. Please check back for updates on the next RFA. You can also subscribe to receive automatic notifications on grants.gov.

 

Past Receipt Dates:

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.

 

Natural History Studies Addressing Unmet Needs of Rare Diseases: Orphan Products Research Project Grant (R01)

Receipt Date: January 10, 2019

FOA Number: RFA-FD-19-001

 

Funding Opportunity Purpose:

The purpose of this funding opportunity announcement (FOA) is to support studies that advance medical product development through the characterization of the natural history of rare diseases/conditions with unmet needs. Through the support of efficient and innovative natural history studies, FDA expects to address critical knowledge gaps, to remove major barrier(s) to progress in the field, to exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and to inform current or future product development including the design of clinical trial(s) and to ultimately inform the development of medical products that meet patient needs.