Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required

The purpose of this funding opportunity announcement (FOA) 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.
Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: National Institutes of Health

Estimated Funding: $1,200,000


Relevant Nonprofit Program Categories





Obtain Full Opportunity Text:
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-001.html

Additional Information of Eligibility:
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U. S. Territory or Possession.

Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-001.html

Contact:


Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

Agency Email:


Date Posted:
2022-06-30

Application Due Date:


Archive Date:
2024-11-27


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