Workshop | Mixed
Event Title
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop
June 8 - 9, 2026
- Date:
- June 8 - 9, 2026
- Day1:
- Mon, Jun 08 8:30 a.m. - 04:30 p.m. ET
- Day2:
- Tue, Jun 09 8:30 a.m. - 04:30 p.m. ET
The workshop will be held as a hybrid (in-person and virtual) meeting. Attendees may join in person at the FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center Room 1503, Silver Spring, MD 20993. Remote attendees may join virtually on Microsoft Teams via the “Join Event” link above.
About This Workshop
The purpose of this annual public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties, as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) science and research priorities.
Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and regulatory assessment of generic products, including complex generics. During the workshop, public input will also be sought on the prioritization of product-specific guidances (PSGs). The sessions of this year’s workshop will focus on identifying what research is needed related to:
- Leveraging Generic Drug Industry Expertise & Insights for GDUFA Research & PSG Prioritization
- Addressing Ongoing Challenges with Impurities such as Nitrosamines
- Expanding Regulatory Flexibility with Bioequivalence Approaches and Standards
- Using Artificial Intelligence (AI) to Address Practical Challenges for Generic Drug Development and Regulatory Assessment
- Standardizing Characterization Test Methods Supporting Bioequivalence and Product Quality
Hybrid (Virtual and In-Person) Options for Attendance
There is no cost to attend the event. Interested parties will have two options to attend this public workshop. Remote attendees may join virtually on Microsoft Teams via the “Join Event” links above. Seating for in-person attendees will be limited to approximately 250 persons and will be available on a first come, first served basis. Individuals can indicate their interest to attend in person by sending an email to GDUFARegulatoryScience@fda.hhs.gov. For parking and security information, please refer FDA’s visitor information page.
Audience
Members of the public including those involved with the generic drug industry, scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs are welcome to attend.
FDA wants your input
FDA seeks ideas on generic drug research topics from the public, the generic drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the FY 2027 research priorities for generic drugs. You may submit your ideas for potential topics for the FY 2027 GDUFA Science and Research Priorities by submitting a comment to the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of July 10, 2026.