Information Session
The U.S. Food and Drug Administration (FDA) will host a virtual Information Session on GDUFA Research Needs & Opportunities for FY 2026 on:
- Date: Wednesday, December 10, 2025
- Time: 11:00 AM – 12:30 PM (Eastern U.S. Time)
- Format: Virtual via Microsoft Teams
- Registration: No registration is required to attend
- Join on Dec 10th: Click Here to Join starting at 11:00 AM
Goal
The goal of this session is to engage researchers in academia and other research organizations whose expertise and capabilities align with the GDUFA Science and Research Priority Initiatives for FY 2026. During the session, FDA scientists will describe specific FY 2026 research needs and opportunities in selected GDUFA priority areas, explaining how this research would accelerate and expand patient access to high-quality, safe, and effective generic medicines.
Agenda
- Overview of GDUFA research priority initiatives for FY 2026, including knowledge gaps and scientific goals
- Brief presentations by FDA scientists on specific FY 2026 research needed in selected priority areas
- Q&A Session to discuss and clarify the research needs, funding opportunities, and expected research outcomes
Proposals
Proposals for research projects in these areas may be submitted in response to the FDA’s Broad Agency Announcement (BAA), under Charge IC Section 7b, which focuses on research that supports and advances generic drug development. To be considered for FY 2026 funding, research proposals must be received by February 24, 2026.
Feel free to share this invitation with colleagues and collaborators who may be interested in developing research proposals aligned with these GDUFA research priorities.
Questions
For questions about the information session or GDUFA research needs, please contact Dr. Sam Raney at GDUFARegulatoryScience@fda.hhs.gov. A link to the meeting recording can be provided to any who request it.