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

Source: https://welltoldgrants.com/grants/for-fd-25-020-clinical-studies-of-orphan-products-addressing-unmet-needs/  
Official notice: https://www.grants.gov/search-results-detail/359987

> Food and Drug Administration plans to offer grants to the applicants described in the notice. It is a forecast, and no dates have been set yet.

| Field | Value |
|---|---|
| Opportunity number | FOR-FD-25-020 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | not set |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- Others (see text field entitled "Additional Information on Eligibility" for clarification)

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 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) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

## What the grant funds

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.

## Questions people ask

### Who can apply for Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?

Food and Drug Administration accepts applications from the applicants described in the notice. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?

Forecast, no dates yet. Confirm the date and time in the official notice on Grants.gov.