FDA Broad Agency Announcement (BAA) — Advancing Regulatory Science

The FDA Broad Agency Announcement for Advancing Regulatory Science sits under the Office of Regulatory and Emerging Science and funds extramural research and development work tied to FDA priorities. Unlike a grant program, this route uses federal contracts, so applicants need to be comfortable bidding into a procurement-style process rather than a standard research-award competition. The announcement covers three areas: modernizing product development and evaluation, strengthening post-market surveillance and labeling, and improving public health preparedness and response. Historical volume shows how much the route has tightened: FY2025 drew 308 applications and 15 awards totaling $16,737,952, while FY2022 peaked at $142,495,425 across 45 awards. For FY2026, applicants must submit a full Concept Paper and Full Proposal together by February 24, 2026; the optional early concept stage was removed, and submissions after that date are held for FY2027 consideration. The route is open to a broad set of organizations, including universities, nonprofits, research groups, and for-profit teams, as long as they can perform the work under contract terms. It is strongest for teams that already understand federal procurement, can write to a precise regulatory-science question, and can move quickly through a formal deadline with a complete technical package.

Each grant below is a distinct funding opportunity with its own eligibility, scope, and deliverables.