OpportunityTitle: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
CategoryExplanation: Eligible Organizations  Higher Education Institutions    Public/State Controlled Institutions of Higher Education  Private Institutions of Higher Education  The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:    o   Hispanic-serving Institutions    o   Historically Black Colleges and Universities (HBCUs)    o   Tribally Controlled Colleges and Universities (TCCUs)    o   Alaska Native and Native Hawaiian Serving Institutions    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)    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)  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)  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 Institutions)
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.
GrantorContactEmailDescription: work email
GrantorContactText: Daniel Lukash &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 240-402-7596
CloseDateExplanation: Two deadlines listed below:October 6, 2020,by 11:59 PM Eastern TimeOctober 5, 2021; by 11:59 PM Eastern Time.