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# Stakeholders Suggest Changes to Ulcerative Colitis Drug Guidance
- URL: https://www.fdaweb.com/stakeholders-suggest-changes-to-ulcerative-colitis-drug-guidance/
- Published: 2022-06-30T12:00:00.000Z
- Updated: 2026-09-14T17:50:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152212

Five major drug companies have commented on and suggested changes to an FDA draft guidance on developing drugs to treat ulcerative colitis. Novartis [says](https://www.regulations.gov/comment/FDA-2022-D-0140-0004?ref=fdaweb.com) it finds the draft to be clear and helpful for the future development of drugs to treat ulcerative colitis and recommends some changes that may further help the development of new medicines for this indication.

Gilead Sciences [provides](https://www.regulations.gov/comment/FDA-2022-D-0140-0006?ref=fdaweb.com) line-by-line comments and recommendations.

Genentech [says](https://www.regulations.gov/comment/FDA-2022-D-0140-0011?ref=fdaweb.com) it believes the draft “will help us optimize drug development for patients with ulcerative colitis.” The company says it wants to understand the extent to which results from clinical trials can be leveraged. “Specifically,” it says, “we would like guidance on whether and how extrapolation can be applied for special populations and combined with expanded enrollment opportunities to allow for therapeutic development.”

AstraZeneca [comments](https://www.regulations.gov/comment/FDA-2022-D-0140-0007?ref=fdaweb.com) that the guidance “addresses well key features including trial population, trial design, efficacy considerations, and safety assessments for clinical trials.” It seeks some clarifications and proposes some changes.

Finally, Pfizer [provides](https://www.regulations.gov/comment/FDA-2022-D-0140-0008?ref=fdaweb.com) line-by-line comments.