Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop

This annual public workshop hosted by the U.S. Food and Drug Administration (FDA) will provide an overview of ongoing science and research initiatives related to generic drugs, as well as an opportunity for public input. The workshop supports FDA’s commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of research priorities specific to generic drugs. Input is sought from stakeholders across the generic drug industry, academia, patient advocacy groups, professional societies, and other interested parties, and will inform the agency’s Fiscal Year 2027 GDUFA science and research priorities.

Workshop discussions will focus on identifying research needs that address scientific knowledge gaps and regulatory challenges impacting generic drug development and assessment, including complex generics. Public input will also be solicited on the prioritization of product-specific guidances (PSGs).

Key topic areas include:

• 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

These sessions are intended to support transparency and collaboration as FDA advances its generic drug research agenda.

Visit the event page for more information.