Navigating the GLP-1 Generic Drug Pathway

This two-day hybrid (virtual and in-person) workshop focuses on exploring the scientific, regulatory, and technical considerations for developing generic GLP-1 products throughout development. The workshop will include comprehensive sessions examining regulatory pathways and clinical context, API characterization and manufacturing, oral formulation development, device design and human factors, and drug-device integration strategies. The program features expert presentations from regulatory scientists across multiple FDA offices, industry leaders from both innovator and generic companies, device manufacturers, and academic researchers, complemented by interactive Q&A panels and small working group discussions for in-person attendees at the end of each day. This collaborative forum aims to advance understanding of the unique challenges in generic GLP-1 development and foster dialogue on best practices, emerging approaches, and regulatory expectations for these complex products.