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Navigating the GLP-1 Generic Pathway: From Peptide to Patient

Date and Time: September 23, 2026 , 8:30 am  –  5:30 pm ,
September 24, 2026 , 8:30 am  –  5:30 pm

Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)

In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.

Registration Coming Soon

This 2-day workshop will address some of the key product development and regulatory assessment considerations for generic GLP-1 agonist products. The goal of this workshop is to bring clarity and promote discussions over evidence-based approaches to establish the acceptable critical quality attributes of recombinant and synthetic peptide products, address manufacturing quality considerations, and tackle the unique challenges associated with drug-device combination products, when applicable.