> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Roche/Genentech Suggestions for nAMD Guidance
- URL: https://www.fdaweb.com/roche-genentech-suggestions-for-namd-guidance/
- Published: 2023-06-01T12:00:00.000Z
- Updated: 2026-09-14T18:35:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154591

Roche/Genentech says an FDA draft guidance on developing drugs to treat neovascular age-related macular degeneration (nAMD) “is well constructed and helpful, outlining essential considerations for the design of clinical studies supporting the registration of therapies for the treatment of nAMD.” The companies [provide](https://downloads.regulations.gov/FDA-2022-D-0073-0011/attachment%5F1.pdf?ref=fdaweb.com) points for further clarification or consideration in the final version of the document.

Their general comments address evolving treatment paradigms, incorporating patient experience data in nAMD product development, and combination product development in nAMD. The letter also contains line-by-line specific comments.