Collaborations to Enhance Drug Development and Regulatory Science
🏛 Food and Drug Administration (HHS-FDA)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for organizations engaged in collaborative drug development and regulatory science research. Typically eligible applicants include academic institutions, research universities, nonprofit research organizations, and private sector entities with demonstrated expertise in pharmaceutical development, clinical trials, or regulatory pathways. The program supports collaborative projects that advance the science underlying FDA's regulatory decisions and accelerate the development of safe, effective drugs. Applicants must have institutional capacity to conduct research, manage federal funds, and comply with FDA regulations. Preference is given to multi-institutional collaborations that bring together complementary expertise to address gaps in drug development science or regulatory understanding.
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Program description
This Notice of Funding Opportunity (NOFO) invites applications for a cooperative agreement to support, manage and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts. FDA and grantees will work together to develop innovative, collaborative projects in research, education, and outreach. These projects can help foster drug product innovation to 1) support efforts to accelerate drug product development; 2) support approaches to advanced manufacturing; 3) facilitate translation of basic science discoveries into therapeutics; and 4) facilitate approaches to enhance the safety, efficacy, quality, and performance of drug products. Projects are identified by FDA. Multiple awards may be funded under this NOFO and are directly dependent on drug development priorities and subject to the availability of funding.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- NIH/SF-424 Application Form or equivalent federal application form
- Project Narrative (typically 15-25 pages) describing research aims, methodology, and regulatory relevance
- Budget and Budget Justification with detailed cost breakdown
- Institutional Biosafety Committee approvals (if applicable)
- Letters of commitment from all collaborating institutions
- Curriculum vitae or biosketches for key personnel
- Project timeline and milestones
- Data management and sharing plan
- Evidence of institutional financial capability and prior grant management experience
Program contact
- 👤 Terrin Brown Grantor
- 📧 terrin.brown@fda.hhs.gov
- 📞 (240) 402-7610
Funding track record
Recent awards under CFDA 93.103 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$121,795,918
-
$76,105,626
-
$50,217,964
-
$47,940,304
-
$36,000,000
-
$35,573,997
-
$35,391,995
-
$30,732,300
-
$23,332,999
-
$21,347,288
Top States by Funding
- AZ 3 awards $131.4M
- MD 7 awards $108.7M
- CA 9 awards $106.5M
- VA 5 awards $96.6M
- PA 10 awards $77.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.103). How funding has trended year over year.
| 2016 | $170,482,435 | |
| 2017 est. | $208,900,832 | |
| 2018 | $173,077,408 | |
| 2019 | $198,507,896 | |
| 2020 | $212,448,590 | |
| 2021 | $218,918,739 | |
| 2022 est. | $255,910,458 | |
| 2023 est. | $246,894,600 |
FAQ
Who is eligible to apply for this grant?
Typically, institutions with research capabilities including universities, academic medical centers, research institutes, nonprofit organizations, and qualified private sector entities can apply. Your institution must be able to manage federal grants and conduct compliant research.
What types of projects are supported?
This program funds collaborative research projects that enhance drug development processes, improve regulatory science, or address scientific gaps that impact FDA's regulatory decision-making. Projects should involve meaningful collaboration between multiple organizations.
What is the typical funding range?
FDA collaborative grants typically range from $300,000 to $1.5 million over a 3-5 year project period, though specific amounts vary by program year and topic.
How competitive is this funding?
This is a moderately competitive federal program. Success depends on scientific merit, clear regulatory relevance, demonstrated collaboration potential, and institutional capacity to execute the proposed research.
When is the next deadline?
Specific deadlines vary by program cycle. Check Grants.gov and FDA's official website for current funding announcements and submission deadlines.
💡 Tips for applicants
- Frame your project clearly around FDA's regulatory science mission and explain how your findings will directly inform regulatory decisions or drug development practices
- Emphasize the strength of your collaborative team and include letters of commitment from all partner institutions detailing their specific roles and contributions
- Include preliminary data or published evidence demonstrating the feasibility of your approach and the expertise of your team members
- Clearly articulate the unmet need or scientific gap your project addresses and why this research is important now
- Budget realistically and justify all costs; include institutional indirect rates and clearly delineate costs by collaborating organization
⚠️ Common mistakes
Applications often lack clear articulation of regulatory relevance and fail to adequately describe how the research will impact FDA's actual regulatory processes. Weak collaboration structures—where partner institutions lack meaningful roles or commitment—are frequently cited reasons for rejection. Additionally, proposals that are too broad, lack sufficient preliminary data, or propose research better suited to other funders tend to score poorly.
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