Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
ArchivedFood and Drug Administration
Description
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.
Who can apply
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities / Indian housing authorities
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Private institutions of higher education
- For-profit organizations other than small businesses
- Small businesses
Contact
Daniel Lukash <br/>Grants Management Specialist <br/>Phone 240-402-7596
daniel.lukash@fda.hhs.gov
- PostedFeb 21, 2020
- ClosesOct 5, 2021
- Award floor$10,000
- Award ceiling$10,000,000
- Expected awards8
- CFDA93.103
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