September 24-25, 2024
Enroll in the Advancing Generic Drug Development Course
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Day One Presentations
Day Two Presentations
About This Course
FDA experts 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 also highlights innovative science and cutting-edge methodologies in generic drug development both within the U.S. and globally.
Topics Covered
- Advancement in vitro characterization methodologies
- Research to support guidance development on complex products including drug-device combination products, topical products, and inhalation products
- Spotlights on recent generic drug review and approval by the FDA
- Efforts to ensure efficient and consistent high quality generic drug development
Learning Objectives
- Stay current with the latest advancements in science, research, guidance development, and regulatory evaluation related to generic drug products.
- Summarize and explain the key enhancements and changes introduced in GDUFA III and their potential impact on ANDAs
- Recognize and explain how the FDA’s 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.
Resources
- GDUFA Science and Research
- Generic Drug Development
- GDUFA III Reauthorization
- Pre-ANDA Program
- Product-Specific Guidances for Generic Drug Development
- Guidances Related to Generic Drugs (under topics, choose “generic drugs ”)