Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products September 10, 2026

Workshop | Virtual

• Date: September 10, 2026
• Time: 8:30 a.m. - 12:40 p.m. ET

This virtual event is FREE!

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Event Details

This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.

FDA uses Generic Drug User Fee Amendments (GDUFA)-funded regulatory science and research to develop and revise general and product-specific guidances and to support abbreviated new drug application (ANDA) review. Case examples will show how research findings have informed guidance recommendations and ANDA assessment.

Attendees will gain practical insights into current FDA BE recommendations, alternative approaches that use modeling and simulation, characterization-based submissions, and how to determine when in vivo studies may be needed for topical and transdermal delivery systems.

Topics

• Current recommendations, implementation challenges, and alternative BE approaches for topical products.
• Case examples showing how GDUFA-funded research has informed guidance revisions, reduced submission deficiencies, and supported ANDA assessments.
• How empirical and in silico research supports product-specific guidances and characterization-based BE approaches, including robust in vitro permeation testing (IVPT) method development.
• Recommendations and implementation strategies for topical and transdermal delivery systems, including how to determine when in vivo studies such as sensitization studies are needed.

Learning Objectives

• Stay up to date on FDA science, guidance recommendations, and regulatory perspectives for topical and transdermal generic drug products.
• Understand how GDUFA-funded research informs general and product-specific guidances and ANDA review.
• Identify strategies and methods that can support efficient development of these complex generics and reduce avoidable bioequivalence deficiencies.

Intended Audience

Scientists, researchers, current and prospective generic drug applicants, regulatory affairs professionals, and others who work on or have an interest in the development of topical and transdermal generic drug products.

FDA Resources

1. GDUFA Science and Research
2. Generic Drug Development
3. GDUFA III Reauthorization
4. Pre-ANDA Program
5. Product-Specific Guidances for Generic Drug Development
6. Guidances Related to Generic Drugs (under Topics, choose "generic drugs")