Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost

Herder Matthew; Morten Christopher J.; Doshi Peter

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Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost

机译：美国食品和药物管理局的综合药物评论 - 法律问题和知识丢失

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This Viewpoint argues against the US Food and Drug Administration's replacement of individual scientific reviews with integrated reviews for new drug approvals.

机译：这一观点旨在驳回美国食品和药物管理局的替代综合评论的个别科学审查，以获得新的药物批准。

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《JAMA internal medicine》 |2020年第5期|共2页
作者
Herder Matthew; Morten Christopher J.; Doshi Peter;
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作者单位

Dalhousie Univ Schulich Sch Law Hlth Law Inst 6061 Univ Ave Weldon Law Bldg POB 15000 Halifax;

NYU Sch Law Engelberg Ctr Innovat Law &

Policy New York NY 10003 USA;

Univ Maryland Sch Pharm Dept Pharmaceut Hlth Serv Res Baltimore MD 21201 USA;

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原文格式 PDF
正文语种 eng
中图分类预防医学、卫生学;
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1. Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost [J] . Herder Matthew, Morten Christopher J., Doshi Peter JAMA internal medicine . 2020,第5期

机译：美国食品和药物管理局的综合药物评论 - 法律问题和知识丢失
2. Integrated Drug Reviews at the US Food and Drug Administration Reply [J] . Doshi Peter, Morten Christopher J., Herder Matthew JAMA internal medicine . 2020,第9期

机译：在美国食品和药物管理局综合评论答复
3. The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates [J] . Watanabe Ko, Murakami Masayasu, Masuyama Koichi, Pharmacoepidemiology and drug safety . 2018,第11期

机译：在批准前药物评估期间对不良反应的关注的关联和审批后的临床上显着的不良反应对包装刀片：对预批准预审药物审查报告和安全更新的回顾性分析
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. A review of the Federal Drug Administration's policy statement on new plant varieties and approval procedures for genetically modified food products. [D] . DeVoe, Meghan Elizabeth. 2014

机译：审查了联邦药品管理局关于转基因食品新植物品种和批准程序的政策声明。
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. Do faster food and drug administration drug reviews adversely affect patient safety? An analysis of the 1992 prescription drug user fee act [O] . Grabowski, H, Wang, YR 2008

机译：更快的食品和药物管理药物审查会对患者安全产生不利影响吗？对1992年处方药使用者费用法的分析

Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost

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