FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway September 23 - 24, 2026

https://www.fda.gov/drugs/news-events-human-drugs/fdacenter-research-complex-generics-crcg-workshop-navigating-glp-1-generic-drug-pathway-09232026?utm_medium=email&utm_source=govdelivery Are you looking to deepen your understanding of regulatory science, innovative analytical approaches, and development strategies for generic GLP-1 drug products? This 2-day hybrid workshop brings together FDA, industry, consulting groups and academic experts to address regulatory challenges and to explore the latest scientific advancements shaping the development of generic GLP-1 products across diverse therapeutic areas. Through a series of presentations and interactive discussions, participants will examine regulatory pathways and clinical contexts for generic GLP-1 products, explore characterization and sameness demonstration strategies, and delve into recombinant peptide manufacturing and host cell impurity characterization and control. The program will also address critical challenges such as Product-Specific Guidance (PSG) development, bioequivalence study design and quality expectations for oral and injectable generic GLP-1 products, device user interface evaluation and considerations for supporting other design differences, and drug-device integration and submission coordination, equipping attendees with the knowledge needed to navigate the regulatory landscape. Choose your experience: Virtual: Access expert presentations and panel discussions from anywhere. In-person: Interact directly with experts from industry, consulting groups, academia and FDA to understand current practices and challenges, regulatory expectations, and emerging trends. Registration fee applies. The in-person component will take place at The Universities at Shady Grove, Rockville, MD. High-engagement scientific interactions will be facilitated through two in-person-only sessions: A session dedicated to informal networking and candid dialogue among subject matter experts about scientific and regulatory challenges for generic GLP-1 products including sections focused on: Device constituents of drug-device combination products Impurities and immunogenicity GLP-1 characterization and sameness Orally administered peptides A guided session for small groups to elucidate and work through specific challenging issues for generic GLP-1 products development and assessment. Don’t miss this opportunity to advance your expertise, network with leading professionals, and help shape the future of generics. For more information, visit https://www.complexgenerics.org/education-training/navigating-the-glp-1-generic-drug-pathway/