FDA CDER SBIA 将于2026年9月10日举办局部及透皮仿制药生物等效性方法现代化虚拟研讨会
Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products - 09/10/2026
FDA CDER SBIA 将于2026年9月10日举办半天虚拟研讨会，讨论局部及透皮仿制药的生物等效性（BE）方法。会议将介绍当前BE建议、建模与模拟等替代方法、基于表征的申报，以及如何判断何时需要体内研究，并结合GDUFA资助研究影响指南修订和ANDA审评的案例。
Workshop | Virtual
Event Title
Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products
- Date:
- September 10, 2026
- Time:
- 8:30 a.m. - 12:40 p.m. ET
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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.
FDA Resources
来源：FDA 官方药品与生物制品信息 · fda.gov