Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop

The Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop is an annual event organized by the U.S. Food and Drug Administration (FDA). This workshop aims to provide an overview of the current status of science and research initiatives for generic drugs and offers a platform for public input on these initiatives. The FDA seeks contributions from the generic drug industry, academia, patient advocates, professional societies, and other interested parties to develop an annual list of science and research initiatives specific to generic drugs.

Key topics to be discussed during the workshop include leveraging generic drug industry expertise for GDUFA research and PSG prioritization, addressing challenges with impurities such as nitrosamines, expanding regulatory flexibility with bioequivalence approaches and standards, utilizing artificial intelligence to address practical challenges in generic drug development and regulatory assessment, and standardizing characterization test methods supporting bioequivalence and product quality.

The workshop will be held as a hybrid event, allowing attendees to participate either in person at the FDA White Oak Campus in Silver Spring, Maryland, or virtually via Microsoft Teams. In-person attendance is limited to approximately 250 participants on a first-come, first-served basis.

This workshop is particularly beneficial for members of the generic drug industry, scientists, researchers, clinicians, regulatory affairs professionals, and patient advocates interested in advancing the development of generic drugs. Attendees will have the opportunity to engage with FDA officials and industry experts, providing valuable input that will inform the FDA's Fiscal Year 2027 Generic Drug User Fee Amendments (GDUFA) science and research priorities.