Bioequivalence and Bioavailability Forum

Dear all,

the CDER Small Business & Industry Assistance (SBIA) is organizing an online public workshop

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.

Agenda
ZIP of Day 1 Slides
ZIP of Day 2 Slides