Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)
This grant opportunity supports clinical trials for rare neurodegenerative diseases that currently lack adequate treatment options. The trials should focus on assessing the safety and effectiveness of medical products to either introduce a new usage or modify existing labeling. The FDA encourages using innovative trial designs to speed up drug development.
This Notice of Funding Opportunity (NOFO) supports clinical trials in all phases of product development for rare neurodegenerative diseases with unmet needs. The trials should evaluate the safety and/or efficacy of medical products in support of a new indication or a change in labeling. The FDA …
Funding Source
Eligibility
Foreign Organizations: Non-domestic (non-U.S.) Entities are eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Encouraged Institutions: The following higher educ…
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