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U.S. Department Of Health And Human Services·Maryland

FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

Closes 2/24/2026$500k – $5MRequest for Proposal
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Description

The FDA is soliciting proposals for advanced research and development to support regulatory science and innovation. The goal is to advance scientific knowledge in specific research areas, including modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. Proposals should focus on one or more of the research areas of interest listed in the announcement, and should include a clear description of the research method, approach, and design, as well as a detailed budget and timeline. • The FDA is seeking proposals that address specific research areas, including new approach methodologies, advanced manufacturing approaches, and analytical and computational methods. • Proposals should include a clear description of the research method, approach, and design, as well as a detailed budget and timeline. • The FDA is looking for proposals that will help advance regulatory science and support the agency's mission to protect and promote public health. • Proposals should be submitted electronically, and should include all required documents and information. • The FDA will review proposals based on their scientific and technical merit, program relevance, and cost evaluation.

Attached files

Contact

Ian Weiss(Primary Contact)

[email protected]

(301) 796-5728

Key dates

Opened
11/21/2025
Pre-bid meeting
1/20/2026
Closes
2/24/2026
Duration
The project duration is not specified, but it is expected to be a multi-year project, with options for continued work at the end of one or more phases.

Last updated

Details

Type
Request for Proposal
Industry
Healthcare and Medical Services
NAICS
541714
Solicitation №
FDABAA-26-00123

Budget estimate

$500,000 – $5,000,000

The budget for this opportunity is difficult to estimate, as it will depend on the specific proposals received and the availability of funds. However, based on the information provided, it appears that the FDA is looking to fund multiple awards, and the amount of each award will depend on the quality of the proposals and the availability of funds. A rough estimate for the budget could be in the range of $500,000 to $5 million, depending on the scope and complexity of the proposed research.

AI estimate from the solicitation

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