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Review of the Food and Drug Administration's Handling of Adverse Drug Reaction Reports.

机译：审查食品和药物管理局处理药品不良反应报告。

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The attached final report presents the results of the Office of Inspector Generals review of the Food and Drug Administrations handling of adverse drug reaction reports. This review was requested by Senator Edward M. Kennedy in a letter dated August 27, 1998 to the Secretary of Health and Human Services.

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年度 1999
页码 1-36
总页数 36
原文格式 PDF
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关键词
Inspector general; US FDA; Investigations; Drug reactions; Congressional inquiries; Data bases; Reporting systems; AERS(Adverse Event Reporting System); Adverse event reporting system;

机译：监察长;美国FDa;调查;药物反应;国会调查;数据库;报告系统; aERs（不良事件报告系统）;不良事件报告系统;

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1. Workgroup Report by the Joint Task Force Involving American Academy of Allergy, Asthma & Immunology (AAAAI); Food Allergy, Anaphylaxis, Dermatology and Drug Allergy (FADDA) (Adverse Reactions to Foods Committee and Adverse Reactions to Drugs, Biologicals, and Latex Committee); and the Centers for Disease Control and Prevention Botulism Clinical Treatment Guidelines Workgroup-Allergic Reactions to Botulinum Antitoxin: A Systematic Review [J] . Schussler Edith, Sobel Jeremy, Hsu Joy, Clinical infectious diseases . 2018,第Suppla1期

机译：涉及美国过敏院，哮喘和免疫学（AAAAI）的联合工作组的工作组报告; 食物过敏，过敏反应，皮肤病学和药物过敏（Fadda）（对食品委员会的不良反应以及对药物，生物和乳胶委员会的不良反应）; 和疾病控制和预防肉类主义的中心临床治疗指南工程群 - 肉毒杆菌抗毒素的过敏反应：系统审查
2. Adverse reaction profiles of hemorrhagic adverse reactions caused by direct oral anticoagulants analyzed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database [J] . Kazuyo Shimada, Shiori Hasegawa, Satoshi Nakao, International Journal of Medical Sciences . 2019,第9期

机译：使用食物和药物管理局的直接口服抗凝血剂引起的出血不良反应的不良反应谱不同，使用食品和药物管理局不良事件报告系统（FAEERS）数据库和日本不利药物事件报告（JADER）数据库
3. Statins and interstitial lung disease: a systematic review of the literature and of food and drug administration adverse event reports. [J] . Fernandez AB, Karas RH, Alsheikh-Ali AA, Chest: The Journal of Circulation, Respiration and Related Systems . 2008,第4期

机译：他汀类药物和间质性肺疾病：文献和食品和药物管理不良事件报告的系统综述。
4. Mining Patients' Reviews in Online Health Communities for Adverse Drug Reaction Detection of Antiepileptic Drugs [C] . Anwar Ali Yahya, Yousef Asiri, Ibrahim Alyami International Arab Conference on Information Technology . 2020

机译：在线卫生社区中的矿产患者评论因抗癫痫药物的不良药物反应检测
5. Labeling of genetically modified foods: Stakeholder perceptions of the Food and Drug Administration's public consultation processes and food industry reactions to the United States voluntary and European Union mandatory policies [D] . Albert, Janice Lee 2007

机译：转基因食品的标签：利益相关者对食品药品监督管理局的公众咨询过程以及食品行业对美国自愿和欧盟强制性政策的反应的看法
6. Workgroup Report by the Joint Task Force Involving American Academy of Allergy Asthma Immunology (AAAAI); Food Allergy Anaphylaxis Dermatology and Drug Allergy (FADDA) (Adverse Reactions to Foods Committee and Adverse Reactions to Drugs Biologicals and Latex Committee); and the Centers for Disease Control and Prevention Botulism Clinical Treatment Guidelines Workgroup—Allergic Reactions to Botulinum Antitoxin: A Systematic Review [O] . Edith Schussler, Jeremy Sobel, Joy Hsu, -1

机译：涉及美国过敏哮喘和免疫学学会（AAAAI）的联合工作组的工作组报告；食品过敏过敏反应皮肤病学和药物过敏（FADDA）（食品委员会的不良反应和药物生物制品和乳胶委员会的不良反应）；和疾病预防控制中心肉毒杆菌中毒临床治疗指南工作组-对肉毒杆菌毒素的过敏反应：系统评价
7. PMC18 COMPARISONS OF DATA MINING ALGORITHMS FOR ADVERSE DRUG REACTIONS: AN EMPIRICAL STUDY BASED ONTHE ADVERSE EVENT REPORTING SYSTEM OFTHE FOOD AND DRUG ADMINISTRATION [O] . Chen Y, Guo JJ, Patel NC, 2008

机译：药物不良反应数据挖掘算法的PMC18比较：基于食品和药物不良事件报告系统的实证研究

Review of the Food and Drug Administration's Handling of Adverse Drug Reaction Reports.

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