Critical Path Public Private Partnerships Clinical Trials Optional
🏛 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 working to accelerate drug and medical device development. Eligible applicants include nonprofit organizations, educational institutions, hospitals, and private companies developing therapeutic products. The program focuses on clinical trial support and regulatory pathway optimization. Geographic scope is U.S.-based organizations, though international collaborators may participate. Priority goes to projects addressing unmet medical needs and using innovative development approaches.
Applicants must have capacity to conduct clinical research. Organizations should demonstrate expertise in drug or device development. FDA regulatory experience is valuable but not always required. Collaborative partnerships between public and private entities are encouraged and may strengthen applications.
The program supports activities including clinical trial design optimization, biomarker development, and regulatory consultation. Funding helps streamline development timelines and reduce costs. Projects addressing rare diseases or pediatric conditions receive priority consideration.
Not the right fit? Find grants for your organization in 5 questions →
Program description
The FDA seeks an application to continue to maintain, manage existing consortia groups convened and established by the Critical Path Institute. This is a renewal of the cooperative agreement #5U18FD005320 as part of the Critical Path Initiative. This is in support of Critical Path Initiative introduced in Section 566 of the Federal Food, Drug, and Cosmetic Act. This includes developing innovative, collaborative projects in research, education, and outreach for fostering drug product innovation, enabling the acceleration of development, manufacturing, and translational therapeutics, enhancing safety, efficacy, quality, and performance. This funding opportunity will provide support, depending on availability of FDA funding.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative describing clinical development strategy
- Budget and budget justification
- Letters of collaboration from partners
- Organizational capacity documentation
- FDA correspondence or regulatory pathway documentation
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 can apply for this grant?
Nonprofits, universities, hospitals, and for-profit companies can apply. You need demonstrated capacity in drug or device development and clinical research.
What activities does this grant support?
The program funds clinical trial optimization, regulatory pathway planning, and biomarker development. It supports activities that accelerate product development and FDA approval.
Is clinical trial experience required?
While helpful, prior clinical trial experience is not strictly required. Strong research capacity and regulatory knowledge increase competitiveness.
How competitive is this program?
This is moderately competitive. Applications addressing unmet medical needs and involving public-private partnerships tend to score higher.
What is the typical funding range?
Award amounts vary widely based on project scope. Awards typically range from several hundred thousand to millions for larger collaborative projects.
💡 Tips for applicants
- Emphasize how your project addresses unmet medical needs. Show clear public health impact and urgency.
- Build partnerships with both public and private sector entities. Collaboration strengthens competitiveness significantly.
- Demonstrate realistic timelines and milestones. Show how FDA feedback will inform your development strategy.
- Detail your regulatory strategy upfront. Explain how you'll engage with FDA throughout the process.
- Include letters of support from clinical trial sites and FDA liaisons. Third-party validation matters.
⚠️ Common mistakes
Applications fail when applicants lack clear clinical development strategies or realistic timelines. Weak partnerships or unclear roles of collaborators reduce competitiveness. Projects without demonstrated unmet medical need or public health significance rarely succeed.
Similar grants
- ROLLING Collaborations to Enhance Drug Development and Regulatory Science — Food and Drug Administration
- ROLLING Cooperative Agreement to Support Effective Dissemination of Clinical Practice Guidelines — Food and Drug Administration
- CLOSED NIH Research Program Projects (Parent P01 Clinical Trial Optional) — National Institutes of Health
- OPEN Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 – Clinical Trial Optional) — National Institutes of Health
- OPEN Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional) — National Institutes of Health