Workshop | Virtual

Event Title

Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products

September 10, 2026

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

This virtual event is FREE!

About this Event (Hosted by CDER SBIA)

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.

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.

Topics Covered

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.

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

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