Note: The annual FREE FDA CDER SBIA Complex Generic Drug Product Development Workshop has been renamed to:
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.
The agenda may be updated. The current version is Version 14, updated September 26, 2020. | The speaker biographies document provides details on the event speakers and panelists. |
Day One Session Slides | Day Two Session Slides |
The session recordings will be linked below once they have been processed.
Day One:
Day Two:
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More Information
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