US FDA’s 2024 Advancing Generic Drug Development Workshop: A Must-Attend Event for Industry Professionals

The FDA’s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) is set to host the highly anticipated 2024 Advancing Generic Drug Development Workshop on September 24-25, 2024.

This workshop is an essential opportunity for professionals in the generic drug industry to stay informed on the latest scientific and regulatory advancements. Whether attending in person or virtually, participants will leave with actionable insights and a better understanding of the future landscape of generic drug development.

Workshop Focus Areas

The workshop will delve into critical topics essential for advancing the generic drug industry, including:

• Advancements in In Vitro Characterization: Explore the latest methodologies enhancing the in vitro characterization of generic drugs.
• Research for Guidance Development: Understand the FDA’s research initiatives aimed at developing guidance for complex products.
• Ensuring Quality and Efficiency: Learn about ongoing efforts to ensure the efficient development and high quality of generic drugs.

Participants will also gain a deeper understanding of the impact of the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program on the development, regulation, and approval of generic drugs.

Workshop Schedule

• Day 1: September 24, 2024, 8:30 AM – 4:35 PM ET
• Day 2: September 25, 2024, 9:00 AM – 4:15 PM ET

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