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# Comments on Immune-Mediated Adverse Reaction Guidance
- URL: https://www.fdaweb.com/comments-on-immune-mediated-adverse-reaction-guidance/
- Published: 2022-12-15T12:00:00.000Z
- Updated: 2026-09-14T18:09:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153411

Responding to an FDA draft guidance on characterizing, collecting, and reporting immune-mediated adverse reactions in cancer immunotherapeutic clinical trials, Bristol-Myers Squibb says it is expected that as new traditions and times of therapy are developed, a better understanding within the healthcare community and the sponsor’s database/experience continue to expand. “Collecting and reporting of immune-mediated adverse reactions are expected to evolve over time,” the company [letter](https://www.regulations.gov/comment/FDA-2022-D-1744-0003?ref=fdaweb.com) says. “Therefore, BMS proposes that this guidance provide recommendations to sponsors on their expectations to collecting and reporting immune-mediated adverse reactions beyond the first approval.”

In its [comment](https://www.regulations.gov/comment/FDA-2022-D-1744-0005?ref=fdaweb.com), Pfizer recommends that FDA consider transitioning away from the classification of adverse events as immune-mediated adverse reactions given the challenges in making such a determination in many cases. The company also includes specific line-by-line comments.

Boehringer Ingelheim [provides](https://www.regulations.gov/comment/FDA-2022-D-1744-0004?ref=fdaweb.com) line-by-line comments.