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

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

Creation Date: 
Monday, February 6, 2012
Closing Date for Applications: 
Tuesday, October 16, 2012
Description: 

The Office of Orphan Products Development (OPD) was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition (that is, one with prevalence, not incidence, of fewer than 200,000 people in the United States). 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 proposed product 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.

 

Department Name: 
Department of Health and Human Services
Expected Number of Awards: 
12
Total Program Funding: 
$4,100,000.00
Award Ceiling: 
$400,000.00
Award Floor: 
$200,000.00
Agency Name: 
Food and Drug Administration (FDA)