Advancing Generic Drug Development: Translating Science to Approval 2025

Join FDA experts at the 2025 Advancing Generic Drug Development Workshop, an in-depth event exploring the transformative impact of the Generic Drug User Fee Amendments (GDUFA) Science and Research Program on generic drug development, regulation, and approval.

This workshop will cover key scientific and regulatory challenges in abbreviated new drug applications (ANDAs), provide insights into GDUFA III progress, and spotlight innovative research in complex generics.

Key Topics Include:

1. Research and methodologies to support guidance development on complex generic products including implant, inhalation, and topical products
2. Innovative methodologies and design recommendations for demonstrating therapeutic equivalence
3. Common regulatory challenges and solutions for generic products with complex drug substances, excipients, and formulations
4. Known issues and practical strategies for addressing nitrosamine contamination in pharmaceutical products

Learning Objectives:

1. Stay up-to-date with the latest advancements in science, research, guidance development, and regulatory evaluation related to generic drug products
2. Recognize and explain how the FDA’s GDUFA-funded research can be leveraged to support and inform generic drug development
3. Utilize various strategies and methodologies to facilitate efficient generic drug development

Visit the event page for more information.