Skip to content

FDA Advancing Generic Drug Development Workshop 2021

Advancing Generic Drug Development:
Translating Science to Approval
September 21-22, 2021

The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval. The 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 the science and cutting-edge methodologies behind generic drug development.

This workshop is part of the SBIA Regulatory Education for Industry (REdI) series and is being offered as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor.

Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda may be updated if any changes occur. The current version is Version 8, updated on September 18, 2021.

PDF Download
Speaker Biographies

The speaker biographies document is being finalized and will be posted here as soon as it is ready.