- Date:
- June 3 - 4, 2025
- Day1:
- Tue, Jun 03 8:00 a.m. - 05:30 p.m. ET
- Day2:
- Wed, Jun 04 9:00 a.m. - 04:30 p.m. ET
Location
The workshop will be hosted 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, Sections B&C, Silver Spring, MD 20993. Remote attendees may join virtually on Microsoft Teams via the “Join Event” link above.
About This Workshop
The purpose of the 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) 2026 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. The sessions of this year’s workshop will focus on what research is needed to clarify implementation details and potential guidance recommendations related to, but not limited to:
- Complex active pharmaceutical ingredients, potentially including immunogenicity issues and challenges for iron products
- Complex products, potentially including inhalation products, complex injectable products, and drug device combination products
- Oral products, potentially including considerations relevant to ICH M13A, challenges with BCS Class IV drugs, and the feasibility of waiver approaches for modified release products
A common theme across the sessions of the workshop will be to consider what research is needed to overcome challenges for generic product development by establishing approaches that integrate evidence from empirical tests or studies with evidence from computational modeling and simulation. Each session of this year’s workshop will include presentations and a panel discussion with representatives from the generic drug industry, academia, and FDA.
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. The workshop will be held on the FDA’s White Oak Campus (10903 New Hampshire Ave, Building 31 Conference Center Room 1503, Sections B&C, Silver Spring, MD 20993). Seating is limited to approximately 250 attendees 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. Remote attendees may join virtually on Microsoft Teams via the “Join Event” link above. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information.
Audience
Members of 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.
FDA wants your input
FDA seeks ideas on generic drug research topics from the drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the FY 2026 research priorities for generic drugs. You may submit your ideas for potential topics for the FY 2026 GDUFA Science and Research Priorities by submitting a comment on the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of July 7, 2025.
