Open now · Grant · RFA-FD-25-020
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.
| Item | Estimate | Note |
|---|---|---|
| Drafting effort | 3–4 weeks | single submission |
| Time to first payment | 6–9 months | cut-off → evaluation → grant agreement |
These are Bemzu's estimates from the call's structure (the number of stages and whether a consortium is required) not figures published by the Commission. Only the co-financing share is read from the call itself.
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