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

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Title:  

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

Agency:  

U.S. Department Of Health And Human Services

State:  

Maryland

NAICS Code:  

541714

Industry:  

Healthcare and Medical Services

Solicitation Type:  

Request for Proposal

Solicitation ID:  

FDABAA-26-00123

Open Date:  

11/21/2025

Pre-Bid Meeting Date:  

1/20/2026

Close Date:  

2/24/2026

Project 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:  

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:

Please visit the bid source via the “Link to Bid Source” button below for documentation.

Contact Information:

Ian Weiss(Primary Contact)

Ian.Weiss@fda.hhs.gov

(301) 796-5728

Budget Estimate (AI):

$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.

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