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.

Session Recordings:

Day One:

• Keynote Address
• COVID-19 Impact on Generic Drug Regulation and Evaluation
• Considerations in Assessing Generic Drug Products of Oral Dosage Forms
• Complex Generics: Complex Injectables, Opthalmic and Otic Products Part 1
• Complex Generics: Complex Injectables, Opthalmic and Otic Products Part 2
• Day One Closing Remarks

Day Two:

• Cutting Edge Science in Complex Generics
• Complex Generics: Nasal and Inhalation Products
• Complex Generics: Topical Products Part 1
• Complex Generics: Topical Products Part 2
• Day Two Closing Remarks