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

https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-modernizing-bioequivalence-approaches-topical-transdermal?utm_medium=email&utm_source=govdelivery Are you developing a topical or transdermal generic drug product? Join this half-day virtual workshop to hear FDA experts discuss current regulatory recommendations, emerging bioequivalence approaches, and research that is helping streamline generic drug development and review. Attendees can ask questions and learn from case examples showing how GDUFA-funded research has informed guidance revisions and ANDA assessments. The workshop will also address characterization-based approaches, modeling and simulation, in vitro permeation testing (IVPT) method development, and recommendations for topical and transdermal delivery systems. Topics Current recommendations, implementation challenges, and alternative bioequivalence 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 bioequivalence approaches, including robust 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 appropriate 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. https://events-na12.adobeconnect.com/content/connect/c1/1315899612/en/events/event/shared/5118822171/event_registration.html?_charset_=utf-8&sco-id=7126601038&utm_medium=email&utm_source=govdelivery