Event Details

Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in abbreviated new drug applications (ANDAs) alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues related to product-specific guidance development, as well as pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development.

Don’t miss this unique opportunity to learn about critical aspects to improve your generic drug development!

Topics

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

Learning Objectives

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

Intended Audience

Scientists, researchers, current and prospective generic drug applicants, and regulatory affairs professionals who work on or have an interest in the development of generic drugs, including complex generic products.