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Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (

The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to

AgencyFood and Drug Administration
StatusForecasted
Opportunity numberFOR-FD-25-017
Posted date07/11/2025
Award ceiling400,000
Award floornone
Who can applyHigher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Local Governments State Governments County Governme
Assistance Listing (CFDA)93.103
DescriptionThe purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
Agency contactKimberly.Pendleton@fda.hhs.gov
Official listinghttps://www.grants.gov/search-results-detail/359985

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