SBIA Education Events

Supporting Events from FDA CDER Small Business & Industry Assistance


Advancing Innovative Science in Generic Drug Development Workshop 2020 Banner

Note: The annual FREE FDA CDER SBIA Complex Generic Drug Product Development Workshop has been renamed to:

Advancing Innovative Science in Generic Drug Development Workshop
September 29 & 30, 2020

The goal of this science-focused workshop is to help the generic industry pave a clear scientific pathway for generic drug development. We will focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.

Agenda & Speaker Bios

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Event Agenda

The agenda may be updated. The current version is Version 14, updated September 26, 2020.

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Speaker Biographies

The speaker biographies document provides details on the event speakers and panelists.

Files, Certificate & Recordings

Day One Session Slides

Day Two Session Slides

Session Recordings:

The session recordings will be linked below once they have been processed.

Day One:

Day Two:

Questions & More Information

Questions?

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More Information

If you have questions regarding the content of the event or other CDER-specific information, please: