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Agenda

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ABOUT THIS MEETING

The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

This year’s theme is Celebrating 10 Years of GDF and presentations will focus on hot topics such as GDUFA III updates, information and technology, and complex generics.

TOPICS COVERED

• Generic Drug User Fee Amendments (GDUFA) through September 2027 (GDUFA III)
• Product Specific Guidances
• ANDA Submissions – Best Practices and Tips
• Policy, Global & Complex Generics Updates
• Information Technology Updates
• Using Orange Book as a Resource

KEYNOTE SPEAKERS

Jacqueline Corrigan-Curay, J.D., M.D
Principal Deputy Center Director
Center For Drug Evaluation and Research (CDER) | FDA

Iilun Murphy, M.D.
Deputy Director for Clinical and Regulatory Affairs
Office of Generic Drugs (OGD) | CDER | FDA

Sau (Larry) Lee, Ph.D.
Deputy Director of Science
Office of Pharmaceutical Quality (OPQ) | CDER | FDA

INTENDED AUDIENCE

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

• plan to submit an ANDA, are in the process of submitting an ANDA, or have submitted an ANDA
• are involved in generic drug development

FDA RESOURCES

• Product-Specific Guidances for Generic Drug Development
• Pharmaceutical Quality Resources
• Industry Resources
• Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
• Federal Register Notices Related to Generic Drugs
• GDUFA Science and Research
• Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book