[Jeff]

Hi Jude, happy to help as well. Here is a link to the FDA’s page for the ESG NextGen:

https://www.fda.gov/industry/electronic-submissions-gateway-next-generation-esg-nextgen/getting-started-esg-nextgen

If you have additional questions or want further pointers, please reach out directly.

fda.gov

Getting Started with ESG NextGen

Getting Started with ESG NextGen