Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities
Closed Posted
- Opportunity number
- RFA-FD-25-023
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications due
- Award size
- Up to $3,000,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- Tribal Organizations (Not Federally Recognized)
- City/Township Governments
- Special District Governments
- State Governments
- Tribal Governments (Federally Recognized)
- Other
- Public or Indian Housing Auth.
- Higher Education Inst. (Public)
- Independent School Districts
- Small Businesses
- County Governments
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- For Profit Organizations
- 501(c)(3) Nonprofits
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research's Office of Compliance, is seeking grant applications to address drug shortage challenges and potential health fraud vulnerabilities. This funding opportunity targets outsourcing facilities, research institutions, nonprofits, businesses, and government entities interested in investigating and mitigating pharmaceutical supply chain disruptions. The primary objectives include understanding the landscape of drug shortage products, identifying opportunities for outsourcing facilities to meet critical medication needs, and supporting research and development efforts to stabilize drug supply chains. Eligible applicants span a wide range of organizational types, including tribal organizations, state and local governments, higher education institutions, and for-profit/non-profit entities. The grant falls under the FDA Research program (CFDA 93.103) and has a submission deadline of August 9, 2025.
While specific award amounts are not explicitly stated, the FDA Research program historically provides grants ranging from $20,000 to over $2,000,000, with project periods typically spanning 1-5 years. The performance locations will predominantly be at recipient institutions, potentially involving multi-site collaborations or engagement with FDA facilities. Successful proposals will likely be evaluated based on their potential to develop innovative approaches to preventing drug shortages, conducting comprehensive research on supply chain vulnerabilities, and proposing actionable strategies to mitigate health fraud risks in pharmaceutical production. The grant aims to support projects that can demonstrate a clear methodology for addressing critical medication availability challenges and improving overall drug supply chain resilience.
Synopsis
The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER)/Office of Compliance (OC)/Office of Compounding Quality and Compliance (OCQC), is announcing this Funding Opportunity Announcement (FOA).
The goals of this grant are to better understand the landscape of drug shortage products, including those vulnerable to health fraud, and identify opportunities for outsourcing facilities to meet drug shortage needs to strengthen the supply chain. Funding would also support outsourcing facilities' research and development of products that mitigate persistent drug shortages to increase supply of critical medications and stabilize the drug supply chain to prevent health fraud.
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