Advancing Generic Drug Development:
Translating Science to Approval 2023
September 13-14, 2023
The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), GDUFA III updates, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA, and ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development.
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The agenda is still being refined and may be updated over time. The current version is v5, uploaded on August 14, 2023.
The speaker biographies document provides detailed information for each of the workshop presenters.
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