Clinical Studies of Safety and Effectiveness of Orphan Products

The summary for the Clinical Studies of Safety and Effectiveness of Orphan Products grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

Clinical Studies of Safety and Effectiveness of Orphan Products: An applicant's eligibity under this grant program is unrestricted, however, we do not have the authority to make awards to individuals. The Office of Orphan Products Development (OOPD) was created to identify and promote the development of orphan products. Orphan products are drugs, biologis, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. The goal of the Food and Drug Administration's (FDA) OOPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy. FDA providces 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 an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development.