FDA/Center for Research on Complex Generics (CRCG) Workshop on Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods October 14 - 15, 2026

https://www.fda.gov/drugs/news-events-human-drugs/fdacenter-research-complex-generics-crcg-workshop-advancing-bioequivalence-frameworks-inhalation?utm_medium=email&utm_source=govdelivery Are you looking to deepen your understanding of regulatory science and innovative bioequivalence strategies for complex generic inhalation drug products? This 2-day hybrid workshop brings together FDA, industry, and academic experts to address the latest bioequivalence methods and their associated challenges shaping the development of complex generic inhalation products. Through a series of presentations and interactive discussions, participants will discuss the current best practices and considerations for using in vitro methods such as realistic APSD, dissolution and particle morphology, charcoal block in vivo pharmacokinetic studies, additional strengths biowaivers, and opportunities to streamline generic development programs. The workshop will also discuss waiver requests and formulation sameness considerations for specific bioequivalence options. Choose your experience: In-person: Engage in collaborative small group working sessions, interact directly with experts from FDA, industry and academia, and participate in immersive group sessions. Virtual: Access expert presentations and panel discussions from anywhere. The in-person component will take place at The Universities at Shady Grove, Rockville, MD. Don’t miss this opportunity to advance your expertise, network with leading professionals, and help shape the future of generic inhalation drug products. For more information, please visit https://www.complexgenerics.org/education-training/advancing-bioequivalence-frameworks-for-inhalation-drug-products-optimizing-in-vitro-in-vivo-and-in-silico-methods/ https://www.complexgenerics.org/education-training/advancing-bioequivalence-frameworks-for-inhalation-drug-products-optimizing-in-vitro-in-vivo-and-in-silico-methods/?utm_medium=email&utm_source=govdelivery