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Info Session on GDUFA Research Needs & Opportunities for FY 2026
Join the FDA for an Information Session on
Generic Drug Research Needs & Opportunities for FY 2026
on January 21, 2026
Join Event (January 21, 2026)
No Registration is Required for this Free Virtual Information Session
Attendance Details
This information session will be hosted virtually on Microsoft Teams. On the day of the event, click the “Join Event” link above to join the session.
Event Details
The U.S. Food and Drug Administration (FDA) is hosting a virtual Information Session on Generic Drug Research Needs & Opportunities for fiscal year (FY) 2026. See additional information below:
- Date: Wednesday, January 21, 2026
- Time: 1:00 PM – 2:30 PM (Eastern U.S. Time)
- Format: Virtual via Microsoft Teams
- Registration: No registration is required to attend
The goal of this session is to engage researchers in academia and other research organizations who may be interested in developing research proposals that align with the FDA’s GDUFA Science and Research Priority Initiatives for FY 2026. During the information session, FDA scientists will describe FY 2026 research needs and opportunities in selected GDUFA priority areas, explaining how specific research would accelerate and expand patient access to high-quality, safe, and effective generic medicines. Following the brief presentations, attendees will have an opportunity to unmute, ask questions, discuss FDA’s goals, and clarify scientific aspects of the research or procedures to submit a proposal for funding consideration.
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.
Intended Audience
Researchers who may be interested in developing research proposals aligned with FDA’s FY 2026 GDUFA research priorities would likely find this information session helpful. Feel free to share this information with colleagues and collaborators who may be interested.
Questions
Please submit questions about the information session or GDUFA research needs to GDUFARegulatoryScience@fda.hhs.gov.
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