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Join us for the FY 2026 Generic Drug Science and Research Initiatives Public Workshop
Date:
June 8-9, 2026
Time:
8:30 am - 4:30 pm EDT on June 8, 2026
8:30 am - 4:30 pm EDT on June 9, 2026
This FREE annual public workshop will 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. FDA will consider the information from the public workshop when developing its future Generic Drug User Fee Amendments (GDUFA) Science and Research Priorities.
The workshop will discuss what 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).
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.
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 to https://www.fda.gov/about-fda/visitor-information.
For more information about the workshop, visit the webpage for this workshop on FDA.gov.
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