Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

In plain English

Food and Drug Administration (Department of Health and Human Services) has announced this as a forecast: an opportunity it expects to post. It is not open for applications yet.

The listing does not state award amounts or the number of awards.

Eligibility is described in the listing text (the "Others" category).

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

• Others (see the eligibility details in the listing)

Additional eligibility information (excerpt from the listing):

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 …

Excerpt from the official forecast on Grants.gov (shortened; read the full text on the official listing):

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.

Read the full forecast on Grants.gov →