Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials

On 17 October 2022 the FDA published the draft guidance on immune-mediated adverse reactions in cancer immunotherapeutic clinical trials for industry.

This guidance provides recommendations regarding the data that should be collected and evaluated to assess whether adverse events qualify as 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.

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