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Clinical Trials
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A supplemental BLA for AstraZeneca’s blockbuster cancer drug Imfinzi (durvalumab) for treatment of nonsmall-cell lung cancer (NSCLC) hit a potential speed bump Thursday in a review by the FDA’s oncology advisory panel of the supporting clinical trial.
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
