At a glance
This program funds clinical trials of orphan products for rare diseases that address unmet needs. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, governments, tribal entities, foreign organizations, and certain community-based and faith-based organizations. The award budget may be up to $650,000 in total costs per year for years 1 through 4, with up to an additional $250,000 per year for innovative and efficient trial approaches, for a maximum of $900,000 per year. The project period can be up to 4 years, with continued support after year 1 depending on annual appropriations, funding availability, performance, and regulatory compliance.
What it funds
Official description from grants.gov
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.
Who can apply
- Others