FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
Award Notice Posted
- Solicitation number
- FDABAA-26-00123_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
- 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 FDA Office of Acquisition and Grant Services awarded 71 contracts totaling $120.774 million in estimated value under the FY26 Broad Agency Announcement for Advanced Research and Development of Regulatory Science, with awards made on September 30, 2026.
The total amount obligated across all contracts is $63.603 million. No set-aside was used. Award recipients include academic institutions (University of Maryland, Purdue University, Duke University, University of Connecticut, Emory University), research organizations (Dana-Farber Cancer Institute, American Type Culture Collection), and private companies (Malcova Inc., Nudge BG Inc., Diagnostic Biochips Inc., Simulations Plus Inc.). Individual contract values range from $256,446 to $6.515 million in obligated amounts. Awards support three primary strategic initiatives: modernizing development and evaluation of FDA-regulated products (majority of awards), strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. Work encompasses advanced pharmaceutical manufacturing, digital health platforms, artificial intelligence applications for regulatory science, bioequivalence studies, lyophilization processes, real-world evidence generation, and patient-focused drug development. The awards span multiple FDA centers including CDER, CDRH, CBER, OCE, CVM, and the Office of Counterterrorism and Emerging Threats.
Notice text
Please see attachment. 53 total awards from the subject announcment.
Awarded contract Please_See_Spreadsheet to Please_See_Spreadsheet for 120774129.00 on 2026-09-30.
Files
| File | Type | Posted |
|---|---|---|
| Final FY26 Awards.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Award Notice | |
| FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | Special Notice |
Similar open opportunities
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity