OpenR01Clinical trial: Required
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Food and Drug Administration · Other Federal · RFA-FD-25-020
Source: Grants.gov · View original posting ↗
- AwardWhat a single award can be worth — the funder's published per-award amount or floor–ceiling range.
- Up to $900K
- DeadlineFinal application due date.
- May 16, 2028
- Letter of intentDue date for the letter of intent (a short pre-application some funders require or request before the full proposal).
- —
- MechanismNIH activity code — the grant type (R01 research project, R21 exploratory, K series career development, F series fellowship, …).
- R01
- DurationMaximum project period for a single award.
- —
- Expected awardsHow many awards the funder anticipates making under this opportunity.
- —
- Funding cycleHow often the program accepts applications (annual, multiple cycles per year, rolling, or one-time).
- One-time
- Open dateWhen applications open (or opened).
- Jul 11, 2025
- Total fundingThe overall pool the funder expects to commit across ALL awards under this opportunity — not what one project receives.
- —
- Clinical trialWhether proposed projects must, may, or must not include a clinical trial.
- Required
Established investigatorForeign entities
Research areas
Therapeutics & drug discoveryClinical trials
Auto-classified from the title and description (keyword-based) — may be imperfect.
Description
The purpose of this Notice of Funding Opportunity (NOFO) 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.