> ## 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.

# Comments on Human Immunogenicity Info Guidance
- URL: https://www.fdaweb.com/comments-on-human-immunogenicity-info-guidance/
- Published: 2022-04-06T12:00:00.000Z
- Updated: 2026-09-14T17:39:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151532

GlaxoSmithKline says an FDA draft guidance on immunogenicity information in human prescription therapeutic protein and select drug product labeling content and format does not address where to place the information for labels subject to regulation at 21 CFR 201.80 rather than the 21 CFR 201.56 and 201.57 shown in the guidance. The company also [notes](https://www.regulations.gov/comment/FDA-2021-D-1041-0004?ref=fdaweb.com) that all of the examples of labeling text provided in the guidance describe the development of anti-drug antibodies, but some patients may have existing antibodies that may cross-react with therapeutic proteins. It suggests language to cover this eventuality.

GSK also provided specific line-by-line comments as did [Bristol-Myers Squibb](https://www.regulations.gov/comment/FDA-2021-D-1041-0005?ref=fdaweb.com) and [Pfizer](https://www.regulations.gov/comment/FDA-2021-D-1041-0006?ref=fdaweb.com).