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), link GDUFA science and research on complex products and scientific issues to product-specific guidance development, and pre-ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development. This workshop will also provide some insight into upcoming GDUFA III enhancements.
Date: September 20 - 21, 2022
Day1: Tue, Sep 20 8:00 AM - 5:10 PM ET
Day2: Wed, Sep 21 8:00 AM - 5:00 PM ET
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