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

Food and Drug Administration

Description

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 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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses

Contact

Vieda HUBBARD <br/>Grants Management Specialist
vieda.hubbard@fda.hhs.gov