FDA BAA Regulatory Science
Funds regulatory science work that strengthens product evaluation and post-market health monitoring.
The FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science is a competitive procurement contracting mechanism, not a grant, administered by the FDA's Office of Regulatory and Emerging Science (ORES) since 2012. It funds extramural research across three regulatory science framework areas: modernizing development and evaluation of FDA-regulated products, stre…
Extramural regulatory science research across three FDA framework areas: modernizing product evaluation, strengthening post-market surveillance, and improving public health preparedness.
Sign up free to see the funding breakdown
Sign up free to see the industries in scope
Sign up free to see the full eligibility
Sign up free to see how to apply
Sign up free to see what you submit
Sign up free to see the timeline
Sign up free to see where teams trip up
Guides for this application
All guides →Grants for Biotech Startups: NIH, NSF, SBIR/STTR, and Non-Dilutive Funding
A practical guide to grants for biotech startups, including NIH SBIR/STTR, NSF, translational funding, evidence, regulatory readiness, and budgets.
DocumentsGrant Work Plan Template: Work Packages, Gantt, Milestones, and Risks
Use this grant work plan template to structure work packages, tasks, owners, deliverables, Gantt timing, dependencies, and risk registers.
Submit & reportSAM.gov Registration and UEI Guide for Federal Grant Applicants
Learn how SAM.gov registration, UEI numbers, Grants.gov accounts, organization profiles, workspace roles, and renewal timing fit together.
BudgetIndirect Costs in Grants: Rates, MTDC, and Examples
Understand indirect costs in grants, including direct vs indirect costs, negotiated rates, de minimis rates, MTDC, funder caps, and budget narrative implications.
More from FDA
All grants from this funder →Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases
FDA · United States
Funds foreign and domestic entities running rare-disease clinical trials through FDA orphan products research grants.
Minor Use Minor Species Development of Drugs
FDA · United States
Funds the safety and effectiveness testing costs of getting a designated new animal drug through FDA approval.
Laboratory Flexible Funding Model (LFFM)
🇺🇸FDA · United States
Funds state, territorial and tribal food- and animal-testing laboratories to run sample testing and lab capacity work for FDA's food safety system.
Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases
FDA · United States
Funds natural history studies that track how a rare disease unfolds over time, to close data gaps blocking new treatments for it.
Animal and Veterinary Innovation Centers
🇺🇸FDA · United States
Funds academic institutions to become long-term FDA partners researching bird flu, animal genomics and unmet veterinary needs.
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases
FDA · United States
Funds clinical trials testing whether a product works and is safe for a rare disease, aimed at a new indication or a labeling change.
Similar grants
Browse the directory →BARDA Accelerator Network — Proof-of-Concept Funding
🇺🇸BARDA · United States
Supports United States health-security teams with early milestone-based funding for proof-of-concept countermeasure work.
DARPA ERIS (Expedited Research Implementation Series)
🇺🇸DARPA · United States
Backs research teams and institutions for DARPA ERIS in defense innovation, biotechnology, and medical technology.
DRIVe EZ-BAA Standard
🇺🇸BARDA · United States
Supports United States health-security innovators during early development stages with streamlined pathway contracting.
DRIVe EZ-BAA Plus Phase (Advanced Development)
🇺🇸BARDA · United States
Funds United States health-security projects transitioning into advanced development after initial defense innovation stages.
NRL Broad Agency Announcement
🇺🇸Navy · United States
Supports naval research collaborations with universities, firms, and consortia for practical outcomes.
DoW SBIR — Open Topics
🇺🇸DoD · United States
Supports United States defense innovators in AI, aerospace, and advanced systems development.