Advancing Generic Drug Development: Translating Science to Approval 2024 (Day 2)

Join us for the 2024 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 ANDAs alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development both within the U.S. and globally.