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PRISM Regulatory Modernization Cooperative Agreement

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Published March 31st, 2026
Detected April 1st, 2026
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Summary

FDA announced the Pathways for Regulatory Innovation and Strategic Modernization (PRISM) cooperative agreement funding opportunity of up to $1.3 million. Applications close April 30, 2026. Only the Reagan-Udall Foundation for the FDA is eligible to apply under this single-source award (RFA-FD-26-007).

What changed

FDA has posted Notice of Funding Opportunity RFA-FD-26-007 for the PRISM cooperative agreement, providing up to $1,300,000 to advance regulatory science modernization. The program supports non-regulatory collaborations to enhance regulatory predictability, efficiency, and transparency across medical products, diagnostics, foods, and digital health.

Eligible applicants must submit applications through Grants.gov by April 30, 2026. This is a single-source opportunity restricted to the Reagan-Udall Foundation for the Food and Drug Administration. No cost sharing or matching is required. Prospective applicants should contact Grants Management Specialist Patrick Johnson at patrick.johnson@fda.hhs.gov for additional information.

Source document (simplified)

Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

Agency: Food and Drug Administration

Assistance Listings: 93.103 -- Food and Drug Administration Research

Last Updated: March 31, 2026 View version history on Grants.gov

Description

The Pathways for Regulatory Innovation and Strategic Modernization (PRISM) cooperative agreement is intended to advance public health by strengthening the scientific, collaborative, and operational foundations needed to modernize regulatory oversight in an increasingly complex and rapidly evolving public health landscape. As innovation in medical products, diagnostics, foods, and digital health accelerates, our nation must continuously adapt its regulatory science approaches to ensure timely access to safe, effective, and high-quality products for the American public. PRISM is designed to support this modernization by enabling forward-looking, non-regulatory collaborations that align with the Commissioner’s strategic priorities and the Administration’s broader public health goals.

PRISM provides a flexible, scalable approach to patient, consumer, industry, academia, and healthcare workforce engagement to generate applied scientific knowledge, tools, and approaches that enhance regulatory predictability, efficiency, and transparency. By leveraging independent expertise and real-world insights, PRISM bridges gaps between innovation and regulation to optimize uptake of emerging technologies, evolving consumer needs, and new sources of evidence such as real-world data and real-world evidence.

Eligibility

Eligible applicants

Miscellaneous

  • Other

Additional information

Only the following applicant is eligible to apply for this single source funding: Reagan-Udall Foundation for the Food and Drug Administration.

Grantor contact information

Description

Patrick Johnson
Grants Management Specialist

Email

Contact Patrick

patrick.johnson@fda.hhs.gov

Documents

Download all
| File name | Description | Last updated |
| --- | --- | --- |
| RFA-FD-26-007PathwaysforRegulatoryInnovationandStrategicModernization.pdf | Notice of Funding Opportunity Announcement (NOFO) | Mar 31, 2026 07:07 PM UTC |

Link to additional information

--

Closing: April 30, 2026

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates. View on Grants.gov

Award

$1,300,000

Program Funding

1

Expected awards

$--

Award Minimum

$1,300,000

Award Maximum

Funding opportunity number:

RFA-FD-26-007

Cost sharing or matching requirement:

No Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

-- Category of Funding Activity:

Agriculture

Consumer protection

Food and nutrition

Health

Category Explanation:

--

History

Version:

2

Posted date:

March 31, 2026

Archive date:

May 30, 2026

Named provisions

PRISM Reagan-Udall Foundation for the FDA

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Published
March 31st, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
RFA-FD-26-007

Who this affects

Applies to
Nonprofits Government agencies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Regulatory Science Research Cooperative Agreements
Threshold
Single-source eligibility limited to Reagan-Udall Foundation for the Food and Drug Administration
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Consumer Protection

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