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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 13 hours ago
, you will learn how to: Describe the role of consumer studies in the FDA's OTC drug approval process and explain why large volumes of verbatim data present challenges for regulatory review. Identify
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 months ago
Office uses literature reviews to synthesize evidence from published literature to support regulatory decision-making. This ongoing project evaluates the large language model (LLM) performance for selected
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 13 hours ago
developing comprehensive toxicology databases and computational models by analyzing proprietary data from drug applications, as well as public literature data, focusing on endpoints where New Approach
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Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 2 months ago
design and interpretation, in-life data collection, endpoint validation, data analysis, and dissemination of results. You will also regularly present and discuss findings at internal meetings attended by
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 13 hours ago
computing infrastructure for OGD. DQMM is also developing innovative quantitative approaches to improve regulatory decision making for generic drugs by fully utilizing the large amount of data available
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 months ago
the evaluation of MDD of topical drug products. You will initially familiarize with FDA’s IT system and take relevant courses and trainings related to clinical trials. Later, you will learn FDA’s Elsa, a large