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FDA Risk Evaluation and Mitigation Strategy Tutorial


Food and Drug Administration - June 22, 2016 FDA要求风险评估及缓解策略(REMS)程式以确保药物获益大于风险。 FDA requiring REMS to ensure that drug benefits outweigh risks.

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Captain Catherine Chew, Pharmacy Manager, FDA: FDA (Food and Drug Administration) may require a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that the benefits of certain drugs outweigh their risks. In June 2015, FDA launched a new and improved REMS website called REMS@FDA. Hi, I'm Captain Catherine Chew, and this is Drug Info Rounds, brought to you by the pharmacists in FDA's Division of Drug Information (DDI). The new REMS@FDA website improves the organization of REMS information online. This makes it easier for users to access comprehensive REMS information. Lieutenant Commander Lindsay Wagner will lead us through a tour of the new website.
LCom Lindsay Wagner, Pharmacy Manager, FDA: Type www.fda.gov/rems, and you'll arrive at the new site. On the homepage, you'll see a searchable and sortable table of current REMS programs. You can search by the name of the REMS, an element of the REMS program, or by an active ingredient with a REMS. After you select a REMS, you'll see the application number, the application holder, and for REMS that cover multiple products, you'll be shown what products are covered by that REMS, and the date the product was added to the REMS. The site features links to the prescribing information from the DailyMed site and to the Drugs@FDA information for a product. Further down the REMS page, you will see "What do participants need to know?" This next section is just for you! Here, we tell healthcare providers and pharmacists what you need to know. You can also find a link to the application holder's website. Depending on the requirements of the REMS, the information that appears will be different. It is now easier than ever to quickly see what is required to prescribe a drug with an approved REMS, or to dispense it to a patient. Scroll further, and you'll find links to REMS materials, including full REMS documents, patient counseling information, training materials, and other documents. Another useful feature of this website is access to the Data Files. Here we provide all of the REMS data, including REMS that are no longer in place. A data dictionary is provided for users.
CC: We're interested in hearing what you think about the REMS@FDA website. Click the "Contact Us" link to share your thoughts. If you have questions about REMS@FDA, call or email FDA's Division of Drug Information.

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    "Active Ingredients" "活性药物成分"◆ Active Pharmaceutical Ingredient (API)
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    administration 【名词】1. 管理,经营;行政 2. 行政机关,局[处、署];(A- 主美)政府; 3. 给与;施行; 4. 给药,(药的)服法; 5. 【军事】后方勤务; 6. 【法律】施行,执行
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    application 应用程序【名词】1. 适用,应用;运用; 2. 申请,请求;申请表格; 3. 勤勉,用功; 4. 敷用;敷用药
  • application holder 申请持有人
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    application number 申请号
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    benefit 【名词】1. 利益,好处;利润 2. 恩惠 3. 义演,义赛; 4. 退休金;(依照社会保险付给的)津贴,救济金,抚恤金; 5. (俚、反)好机会,好差事; 【及物动词】对…有利,有益于…;使得利益; 【不及物动词】得益,受益
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    commander 指挥官【名词】1. 指挥者;【军事】指挥官,司令官; 2. 【海军】中校,副舰长; 3. 木槌
  • comprehensive 全面地; 广泛地; 综合地
  • counseling 咨询服务
  • data dictionary 资料字典;数据字典
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    dispense 【及物动词】1. 配(药),配(方);发(药) 2. 分配;发放 3. 【法律】执行;实施) 【不及物动词】免除,豁免
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    Division of Drug Information 药物谘询部门
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    documented 记录的; 有案可查
  • drug administration 药品监督管理; 给药; 服药
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    drug information 药品信息
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    drugged 【及物动词】用药麻醉;使服药;使服毒品
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    evaluation 评价【名词】1. 估价,评价; 2. 【数学】赋值,值的计算
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    FDA website 食品药品监督管理局(FDA)的网站◆ Food and Drug Administration
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    filing 归档【名词】1. 锉;锉磨;锉法; 2. (常 pl.)锉屑
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    finding 【名词】1.发现,发现物,调查的结果,研究结果; 2. 裁决,定罪 【动词原形】find
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    healthcare 医疗保健;医疗卫生;健康服务
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    healthcare provider 医疗保健提供者
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    hearing 聆讯 【名词】1. 听(动作或过程); 2. 听力,听觉; 3. 发言机会; 4. 审问; 5. 听得见的范围; 6. 意见听取会
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    in place 现有
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    ingredient 【名词】原料;组成部分
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    interest 利益【名词】兴趣,利息,感兴趣,权益,利率,趣味,关注,关心,爱好
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    mitigation 缓解【名词】镇静,缓和;减轻
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    multiple 多个【名词】1. 【数学】倍数; 2. 【电学】并联;多路系统; 3. 相联成组; 4. 成批生产的艺术品(画、雕塑、工艺品等); 【形容词】1. 多重的;复合的; 2. 倍数的,倍; 3. 【电学】并联的;多路的,复接的; 4. 【植物学】聚花的
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    multiple products 多样性产物
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    New and Improved 新的并且改进的
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    no longer 不再
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    outweigh 【及物动词】比…重;比…重要;胜过,强过
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    participant 参与者【名词】与会者,嘉宾,参赛者
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    patient counseling 患者咨询服务
  • patient counseling information 患者咨询服务信息
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    pharmacist 药剂师;药学家;调剂员
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    pharmacy 药房 【名词】1. 配药学,药学; 2. 制药业; 3. 药房; 4. (一批)备用药品
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    pharmacy manager 药店经理
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    prescribe 【及物动词】1. 处方;嘱咐(疗法) 2. 命令;指示;规定;限制 3. 【法律】使(过限期而)失效 【不及物动词】1. 开药方,给医嘱 2. 命令;指示;规定 3.【法律】(长期占有)要求权利;(因过期限而)失效
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    prescribing information 处方信息说明
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    provider 提供程序【名词】1. 供给者,准备者; 2. 需供养家庭的人
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    questioning 1. 疑问;质问 2. 询问; 审问
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    Risk Evaluation and Mitigation Strategy 风险评估及缓解策略◆【略】REMS
  • scroll 滚动【名词】涡旋,卷轴,长卷,秘笈,秘籍,蜗壳,画卷;【及物动词】向下滚动,卷动
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    searchable 搜索
  • searchable and sortable table of current REMS programs 现行风险评估及缓解策略程式的可检索分类表◆ Risk Evaluation and Mitigation Strategy
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    strategy 战略【名词】1. 战略(学); 2. 策略,作战方针
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    training 培训【名词】训练,培养,训,锻炼
  • training material 培训材料
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