Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy.

FDA provides grants for clinical studies on safety

credit: Flickr


and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.

Applicants must include in the application's Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a “rare disease or condition” and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Related Programs

Food and Drug Administration Research

Department of Health and Human Services


Agency: Food and Drug Administration

Office:

Estimated Funding: $14,100,000


Who's Eligible


Relevant Nonprofit Program Categories



Obtain Full Opportunity Text:
NIH Guide

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

Full Opportunity Web Address:


Contact:


Agency Email Description:


Agency Email:
daniel.lukash@fda.hhs.gov

Date Posted:
2014-12-09

Application Due Date:
2018-10-18

Archive Date:
2018-11-17


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