FDA gives thumbs-up to redesigned labels for some Merck meds

Jim Butschli

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FDA gives thumbs-up to redesigned labels for some Merck meds

机译：FDA同意默克某些药品的重新设计标签

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Add pharmacy selection errors, a major pharmaceutical manufacturer, labels, and the U.S. Food and Drug Administration, and it may well sound like an alarming recipe. But that's not the case this time. In fact, in a June 10 announcement, the U.S. Food and Drug Administration announced the "approval of Merck's redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation." Janet Woodcock, M.D., and director of the FDA's Center for Drug Evaluation and Research (CDER), said, "We commend Merck for their efforts. This was no small undertaking, and we are hopeful that Merck's new standardized labels will aid in reducing pharmacy selection errors." FDA's release says Merck's Label Standardization Project includes the revision of 34 container labels for 16 solid oral drugs regulated by CDER.

机译：加上药房选择错误，主要的药品生产商，标签和美国食品药品监督管理局，这听起来像是一个令人震惊的食谱。但这不是事实。实际上，在6月10日的公告中，美国食品药品监督管理局宣布“批准默克公司重新设计的药品容器标签，其中包括一种新的标准化格式，以提高可读性并提供有关产品和强度差异的更好信息。” FDA药品评估与研究中心（CDER）主任珍妮特·伍德科克（Janet Woodcock）表示：“我们赞扬默克所做的努力。这是一项不小的任务，我们希望默克新的标准化标签将有助于减少药房销售。选择错误。” FDA的公告称，默克的标签标准化项目包括对CDER监管的16种固体口服药物的34种容器标签进行修订。

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《Packaging world》 |2011年第9期|p.16|共1页
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Jim Butschli;
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1. FDA APPROVES MERCK'S REVISED LABELS [J] . Self-Adhesive Materials and Markets Bulletin Group Self-Adhesive Materials and Markets Bulletin. . 2011,第9期

机译：FDA批准MERCK的修订标签
2. IMPORTANCE OF CLINICAL OUTCOME ASSESSMENT (COA) DATA IN THE EVALUATION OF MEDICINES FOR THE TREATMENT OF RESTLESS LEGS SYNDROME (RLS): A REVIEW OF THE LABELS OF MEDICINES APPROVED BY THE FDA AND THE EMA [J] . Perrier L., Emery M., Anfray C., Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research . 2017,第5期

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3. IMPORTANCE OF CLINICAL OUTCOME ASSESSMENT (COA) DATA IN THE EVALUATION OF MEDICINES FOR THE TREATMENT OF ALZHEIMER'S DISEASE (AD): A REVIEW OF THE LABELS OF MEDICINES APPROVED BY THE FDA AND THE EMA [J] . Perrier L., Emery M., Anfray C., Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research . 2017,第5期

机译：临床结果评估（COA）数据在治疗Alzheimer疾病的评估中的重要性（AD）：对FDA和EMA批准的药物标签审查
4. DESIGN FOR FDA: A PREDICTIVE MODEL FOR THE FDA'S DECISION TIME FOR MEDICAL DEVICES [C] . Lourdes A. Medina, Gul E. Okudan Kremer, Saylisse Davila, ASME International Design Engineering Technical Conferences . 2014

机译：FDA设计：FDA医疗设备决定时间的预测模型
5. Project Management Practices and Key Factors for Success in FDA Human Factors Validations of Medical Devices and Combination Products =Prácticas de gestión de proyectos y factores clave para el exito en FDA validaciones de factores humanos de dispositivos [D] . Rojas, KM. 2020

机译：项目管理实践和FDA人类因素成功的关键因素医疗设备和组合产品的验证= FDA人类因素验证设备的项目管理和因素管理实践
6. FDA’s Proposed Rule for Pregnancy and Lactation Labeling: Improving maternal child health through well-informed medicine use [O] . Karen B. Feibus 2008

机译：FDA拟议的怀孕和哺乳标签规则：通过充分知情的药物使用改善孕产妇的健康
7. ISMP to FDA: Guidance needed for labeling on compounded meds [O] . Loren Bonner 2018

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FDA gives thumbs-up to redesigned labels for some Merck meds

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