FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
Award Notice Posted
- Solicitation number
- FDABAA-25-00123_Award
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Awarded
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- Please_see_Spreadsheet-Please_see_Spreadsheet
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science, issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services, resulted in a total of 15 contracts awarded on September 30, 2025, with a combined obligation of approximately $16.7 million. The awarded contracts support advanced research and development across multiple scientific disciplines, including machine learning and artificial intelligence applications, clinical trial design and modernization, bioprocessing operations, vaccine technologies, medical countermeasures, digital health innovations, and pharmaceutical development. Individual contract values range from $288,274 to $3,090,714.59, with most awards falling between $500,000 and $1,200,000, demonstrating substantial federal investment in cutting-edge regulatory science research. Award recipients include academic institutions such as Rutgers University, Johns Hopkins University, Duke University, and Florida State University, as well as specialized research organizations, collectively advancing FDA's regulatory science capabilities across multiple research centers including CDER, CDRH, CTP, and OCE.
Notice text
3 versions
Update #3 · Latest ·
Amendment 02 - updated Spreadsheet to include an additional Award
Amendment 01- updated Spreadsheet to include an additional Award
Please see attached Spreadsheet for all contracts awarded in this oppertunity. A total of 15 Contracts were awarded in FY25 from this BAA Announcement.
Awarded contract Please_see_Spreadsheet to Please_see_Spreadsheet for 16737952.78 on 2025-09-30.
Update #2 ·
Amendment 01- updated Spreadsheet to include an additional Award
Please see attached Spreadsheet for all contracts awarded in this oppertunity. A total of 13 Contracts were awarded in FY23 from this BAA Announcement.
Awarded contract Please_see_Spreadsheet to Please_see_Spreadsheet for 15726011.89 on 2025-09-30.
Update #1 ·
Please see attached Spreadsheet for all contracts awarded in this oppertunity. A total of 13 Contracts were awarded in FY23 from this BAA Announcement.
Awarded contract Please_see_Spreadsheet to Please_see_Spreadsheet for 15726011.89 on 2025-09-30.
Files
| File | Type | Posted |
|---|---|---|
| AwardsFY25Data.pdf | ||
| BAATrackingSheet_AwardsFY25Data-01-08-2026.pdf | ||
| BAATrackingSheet_AwardsFY25Data-11-20-25.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Award Notice | |
| FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | Special Notice |
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