The Generic Drug User Fee Amendments (GDUFA) are central to FDA oversight of generic drug manufacturers, but navigating the requirements isn’t always straightforward. Self-identification, program fees, and DMF submissions create recurring challenges that can be costly if misunderstood or overlooked.
In this session, Melissa Sayers, Drug Regulatory Manager, will simplify the complexities of GDUFA and provide practical guidance to help you stay ahead of FDA requirements.
You’ll walk away with a clear understanding of:
- Who must self-identify with FDA—and how this information is used to determine annual program fee obligations
- The structure of GDUFA program fees—including annual facility fees, ANDA holder program fees, and Drug Master File (DMF) fees
- How FDA assesses these fees and the impact on your business operations
- Key compliance considerations under GDUFA III that can help you anticipate obligations and avoid costly missteps
This focused webinar will equip manufacturers, DMF holders, and regulatory professionals to manage costs strategically, strengthen compliance, and ensure smooth market entry under GDUFA.
