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.
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.