Opportunity Information: Apply for RFA FD 25 020
This funding opportunity is a Food and Drug Administration (FDA) grant announcement that supports clinical trials of orphan medical products intended to address unmet needs in rare diseases or rare conditions. The central goal is practical and regulatory-facing: to generate clinical evidence on efficacy and/or safety that can be used to support either a new indication for an existing product or a change in product labeling. In other words, the FDA is looking to fund trials that produce data with a clear path to informing regulatory decisions and ultimately improving available treatment options for patients with rare diseases, where therapies are often limited or nonexistent.
The NOFO emphasizes not only running clinical trials, but doing so in ways that strengthen the rare disease development ecosystem. FDA specifically signals interest in trials that are collaborative, efficient, and/or innovative. That typically means study designs and operational approaches that can work well in rare disease settings, where patient populations are small, sites may be geographically dispersed, and natural history data can be limited. The broader intended impact is to increase the number of approved treatments for rare diseases and to create ripple effects that make future rare disease trials easier, faster, and more informative.
Mechanically, this is an R01-style clinical trial grant (clinical trials required), issued as a discretionary grant under the FDA. The opportunity is listed under CFDA 93.103, and it is categorized within Agriculture, Consumer Protection, Food and Nutrition. The funding opportunity number is RFA-FD-25-020, and it is described as a reissue of an earlier announcement (RFA-FD-23-001), signaling continuity in FDA priorities and an ongoing commitment to this type of clinical development support.
A wide range of applicant types are eligible. Eligibility extends across higher education institutions (public and private), nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses and larger companies), and multiple levels of government (local, county, state, tribal, territorial, and federal). The eligible applicant list also includes independent school districts, public housing authorities/Indian housing authorities, faith-based and community-based organizations, and regional organizations. Importantly for global rare disease research networks, non-U.S. entities are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. This broad eligibility is consistent with how rare disease research is often conducted, since expertise and patients may be distributed internationally.
Key administrative details provided in the source include an award ceiling of $900,000 and an original closing date of May 16, 2028, indicating a multi-year window in which applications may be accepted according to the announcement’s schedule. While the expected number of awards is not specified in the provided text, the ceiling gives a sense of the maximum funding level per award under this notice. The opportunity was created on July 11, 2025, which helps place it in the timeline of FDA’s orphan product development efforts.
In practical terms, this NOFO is best suited for applicants who already have a product and a credible clinical development plan aimed at a specific rare disease unmet need, and who can justify how the proposed trial will produce interpretable safety and efficacy data relevant to labeling or indication changes. Competitive projects are likely to be those with a realistic recruitment strategy for small populations, strong clinical endpoints (or well-justified surrogate endpoints), and an operational plan that shows the trial can be executed efficiently despite common rare disease constraints. The FDA’s framing makes clear that they are not simply funding exploratory research; they are investing in clinical studies that can meaningfully advance a product toward regulatory outcomes and patient access.Apply for RFA FD 25 020
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on 2025-07-11.
- Applicants must submit their applications by 2028-05-16.
- Each selected applicant is eligible to receive up to $900,000.00 in funding.
- Eligible applicants include: Others.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: FDA Orphan Medical Products Clinical Trials Grant (RFA-FD-25-020)
What is this funding opportunity?
This is a Food and Drug Administration (FDA) discretionary grant announcement to support clinical trials of orphan medical products for rare diseases or rare conditions, with the aim of generating clinical evidence on efficacy and/or safety.
What is the main goal of the grant?
The central goal is to fund clinical trials that produce practical, regulatory-facing evidence that can support either (1) a new indication for an existing product or (2) a change in product labeling. The focus is on producing data with a clear path to informing FDA regulatory decisions and improving treatment options for patients with rare diseases.
Are clinical trials required under this opportunity?
Yes. This is described as an R01-style clinical trial grant and the announcement specifies that clinical trials are required.
What types of products are intended to be supported?
The opportunity supports clinical trials of orphan medical products intended to address unmet needs in rare diseases or rare conditions. The emphasis is on products that can be advanced through clinical evidence generation toward regulatory outcomes such as labeling or indication changes.
Is the FDA looking for exploratory research or later-stage clinical evidence?
Based on the description provided, the FDA is not simply funding exploratory research. The intent is to invest in clinical studies that can meaningfully advance a product toward regulatory outcomes and patient access, supported by interpretable efficacy and/or safety data.
What does the FDA mean by "regulatory-facing" evidence?
In this context, "regulatory-facing" evidence means clinical trial data on safety and/or efficacy that is designed to be usable in support of regulatory decisions, including supporting a new indication for an existing product or changes to product labeling.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-25-020.
Is this opportunity new or related to a prior FDA announcement?
It is described as a reissue of an earlier announcement, RFA-FD-23-001, indicating continuity in FDA priorities and ongoing commitment to supporting this type of clinical development for orphan products.
What CFDA listing is associated with this opportunity?
The opportunity is listed under CFDA 93.103.
How is the opportunity categorized?
It is categorized within Agriculture, Consumer Protection, Food and Nutrition.
What is the maximum award amount (award ceiling)?
The award ceiling provided is $900,000.
Is the expected number of awards stated?
No. The provided information notes that the expected number of awards is not specified in the text.
When was the opportunity created?
The opportunity was created on July 11, 2025.
What is the closing date for the opportunity?
The original closing date listed is May 16, 2028, indicating a multi-year window in which applications may be accepted according to the announcement schedule.
Who is eligible to apply?
A wide range of applicant types are eligible, including:
- Higher education institutions (public and private)
- Nonprofit organizations (with or without 501(c)(3) status)
- For-profit organizations (including small businesses and larger companies)
- Government entities (local, county, state, tribal, territorial, and federal)
- Independent school districts
- Public housing authorities / Indian housing authorities
- Faith-based and community-based organizations
- Regional organizations
Are non-U.S. organizations eligible?
Yes. Non-U.S. entities are eligible to apply. In addition, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement.
Why does the opportunity allow foreign applicants and components?
The provided description explains that rare disease research and expertise (and patient populations) are often distributed internationally, and broad eligibility aligns with how global rare disease research networks operate.
What kinds of trial approaches does the FDA signal interest in?
The FDA signals interest in trials that are collaborative, efficient, and/or innovative, especially approaches that work well in rare disease settings where patient populations are small, sites can be geographically dispersed, and natural history data may be limited.
What broader impact is the FDA aiming for beyond individual trials?
Beyond running clinical trials, the NOFO emphasizes strengthening the rare disease development ecosystem. The intended impact is to increase the number of approved treatments for rare diseases and create "ripple effects" that make future rare disease trials easier, faster, and more informative.
What types of projects are likely to be a good fit for this NOFO?
The opportunity is described as best suited for applicants who already have a product and a credible clinical development plan aimed at a specific unmet need in a rare disease or condition, and who can justify how the proposed trial will generate interpretable safety and efficacy evidence relevant to labeling or indication changes.
What characteristics are highlighted for competitive proposals?
Based on the information provided, competitive projects are likely to include:
- A realistic recruitment strategy for small rare disease populations
- Strong clinical endpoints, or well-justified surrogate endpoints
- An operational plan demonstrating the trial can be executed efficiently despite common rare disease constraints
- Trial designs and operations that are collaborative, efficient, and/or innovative
Does the NOFO focus on efficacy, safety, or both?
It focuses on generating clinical evidence on efficacy and/or safety, with the intent that the evidence can be used to support regulatory actions such as new indications or labeling changes.
How does the NOFO address common challenges in rare disease trials?
The description specifically points to challenges such as small patient populations, geographically dispersed sites, and limited natural history data, and it indicates FDA interest in collaborative, efficient, and innovative approaches suited to these constraints.
What kind of regulatory outcome is the FDA trying to enable through funded trials?
The stated regulatory outcomes include supporting a new indication for an existing product or supporting changes to product labeling, based on trial-generated evidence of safety and/or efficacy.
Browse more opportunities from the same category: Agriculture, Consumer Protection, Food and Nutrition
Next opportunity: Value-Added Producer Grant
Previous opportunity: Advancing Secure Digital Connectivity in Paraguay
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 25 020
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 25 020) also looked into and applied for these:
| Funding Opportunity |
|---|
| Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities Apply for RFA FD 25 023 Funding Number: RFA FD 25 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| FDA's Integrated Food Safety System Training Delivery and Development Apply for RFA FD 25 016 Funding Number: RFA FD 25 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Establishing the Integrated Food Safety System (IFSS) Regulatory and Laboratory Training System (RLTS) National Coordination Center (NCC) and Learning Management System (LMS) Apply for RFA FD 25 005 Funding Number: RFA FD 25 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,750,000 |
| Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional Apply for RFA FD 25 015 Funding Number: RFA FD 25 015 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs Apply for RFA FD 25 022 Funding Number: RFA FD 25 022 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers Apply for RFA FD 26 004 Funding Number: RFA FD 26 004 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 25 020", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.