2022-22617: Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials." This guidance is intended for sponsors of cancer immunotherapeutic drugs that modulate the endogenous immune system and may break immunologic tolerance to normal organs and tissues; it provides recommendations regarding the data that should be collected and evaluated to assess whether adverse events are immune-mediated adverse reactions (imARs) and the data on imARs that should be included in a new drug application (NDA) or biologics license application (BLA) for a cancer immunotherapeutic drug.
The agency’s own summary, as published.
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