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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 · RFA-FD-25-020 · Deadline: May 16, 2028 · Advertised ceiling: $900k

Program-level history — this opportunity doesn't publish per-opportunity awards, so these numbers describe its parent program (CFDA 93.103, Food and Drug Administration Research), not this competition alone. Labeled that way on purpose.

Ask-amount guidance

Applicants here typically receive far less than the advertised ceiling: the program median is $500k against a $900k ceiling (56%). Budgets far above the median need a story; budgets far below leave money on the table.

Draw-down reality (program)

Across 205 completed awards in this program (FY2021+ sample, USAspending outlay records), grantees ultimately drew a median 100% of obligated funds. A median well under 100% means underspend or early closure is common here — worth knowing before promising a spend-down timeline.

Listing summary

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.

Eligibility: Others · Categories: Agriculture, Consumer Protection, Food and Nutrition · official listing ↗

Sources: NIH RePORTER (opportunity-exact) and USAspending (program-level), labeled per section. GrantsDue computes summaries only; verify anything critical against the originals. Methodology.