Celia Witten
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Detailed Analysis
Inspector Celia Witten takes a meticulous and comprehensive approach, ensuring all relevant data regarding efficacy, safety, adverse events and risk management strategies is carefully reviewed. She places strong emphasis on the risk mitigation strategies and often focuses on how well the company is prepared for post-marketing surveillance of adverse events.
FDA Inspector Celia Witten appears to focus mainly on efficacy, safety and adverse events related to drug use during her inspections. She is thorough in her examinations and gives particular attention to clinical trials data and post-marketing adverse events recordings. She demonstrates interest in how risks associated with the drugs are mitigated and is always keen to ensure that the companies appropriately manage these risks.
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