Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
Key Information
Due Date: September 22, 2024
Agency: U.S. Department of Health and Human Services (HHS)
Source: Federal
Funding Category:
Health & Human Services
Funding Amount: $581,371
Funding Type: Grant, Government
Match Required: No
Contact Info:
shashi.malhotra@fda.hhs.gov
Overview
The Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) grant is designed to fund clinical trials of products that are being developed to treat rare diseases or conditions. The goal of these trials is to assess the efficacy and/or safety of these products, with a view to supporting their new use or change in labeling. By funding these trials, the FDA hopes to encourage collaboration, efficiency, and innovation in clinical trials. Ultimately, the FDA hopes to increase the number of approved treatments for rare diseases and to have a wide and positive effect on the development of drugs for rare diseases.
Show More
Key Dates
Open Date: July 5, 2022
Application Due Date: September 22, 2024
Estimated Award Date: Not Specified
Additional Details
Eligible Activities
- Research and Development
Eligible Applicants
- State governments
- County governments
- City, village or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Private institutions of higher education
- Small businesses