OpportunityTitle: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
AdditionalInformationOnEligibility: Higher 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 Governments  City or Township Governments  Special District Governments  Indian/Native American Tribal Governments (Federally Recognized)  Indian/Native American Tribal Governments (Other than Federally Recognized)  Federal Governments&#160;    U.S. Territory or Possession    Other    Independent School Districts  Public Housing Authorities/Indian Housing Authorities  Native American Tribal Organizations (other than Federally recognized tribal governments)  Faith-based or Community-based Organizations  Regional Organizations  Non-domestic (non-U.S.) Entities (Foreign Organizations)      Foreign Organizations    Non-domestic (non-U.S.) Entities (Foreign Organizations)&#160;are&#160;eligible to apply.    Non-domestic (non-U.S.) components of U.S. Organizations&#160;are&#160;eligible to apply.
Description: The purpose of this opportunity is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.
GrantorContactEmailDescription: Business e-mail address