Clinical Studies of Orphan Products Addressing Unmet Needs of Rare...

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. Cooperative Agreement

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