about
Advantages of a Truly Open-Access Data-Sharing Model.Regulatory watch: From big data to smart data: FDA's INFORMED initiative.U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.Lifetime exposure to a soluble TGF-beta antagonist protects mice against metastasis without adverse side effectsOverall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses.Using the hierarchy of control technologies to improve healthcare facility infection control: lessons from severe acute respiratory syndrome.Hepatoid carcinoma of the lung with anaplastic lymphoma kinase gene rearrangement.18F-fluorodeoxyglucose positron emission tomography in the management of patients with thymic epithelial tumorsSelumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced nonsmall-cell lung cancer.A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.Concurrent molecular alterations in tumors with germ line epidermal growth factor receptor T790M mutations.Cixutumumab for patients with recurrent or refractory advanced thymic epithelial tumours: a multicentre, open-label, phase 2 trial.FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.Clinician Perspectives on Current Issues in Lung Cancer Drug Development.Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.The effects of adrenalectomy and aldosterone replacement in transgenic mice expressing antisense RNA to the type 2 glucocorticoid receptor.Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.Real-world Data for Clinical Evidence Generation in Oncology.Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA.U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.Response to crizotinib in ROS1-rearranged non-small-cell lung cancer.Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?The Majority of Expedited Investigational New Drug Safety Reports Are UninformativeINFORMED: an incubator at the US FDA for driving innovations in data science and agile technology
P50
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P50
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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Sean Khozin
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P106
P21
P31
P496
0000-0003-2206-7620