This funding opportunity supports clinical trials of products aimed at evaluating efficacy and safety to obtain new indications or labeling changes addressing unmet needs in rare diseases. It encourages collaborative, efficient, and innovative clinical trials to increase approved treatments and positively impact rare disease drug development.
Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, for-profit organizations, government entities, tribal governments, and foreign organizations. Both domestic and foreign components of organizations may apply.