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FDA's (Federal Drug Administration) Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies

机译：FDa（联邦药物管理局）对新药的评论：审查和报告临床研究过程中所需的变化

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Assuring American consumers that new drugs and biologics entering the marketplace are safe and effective is a responsibility of the Food and Drug Administration (FDA). Through inspections and reviews, FDA's Division of Scientific Investigations attempts to verify the integrity of scientific testing and the reliability of test data submitted to FDA in support of new drug applications. GAO reviewed the Division's activities, including its responsibilities relating to the approval of new drug and biologic products; the accuracy of FDA data and adequacy of oversight regarding clinical investigators, institutional review boards, and toxicology laboratories involved in studies supporting new drug applications; FDA's review of studies by clinical investigators supporting new drug applications; the adequacy and timeliness of for-cause (specially requested) inspections; and enforcement actions resulting from the Division's work. GAO also examined the timeliness of the Division's inspections. (aw)

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作者
Pennington, J. C.;
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年度 1988
页码 p.1-33
总页数 33
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Clinical medicine; Drugs; Toxicology; Accuracy; Biology; Consumers; Experimental data; Food; Laboratories; Reliability; Test and evaluation; Timeliness; United States government;

机译：临床医学;药物;毒理学;准确性;生物学;消费者;实验数据;食品;实验室;可靠性;测试和评估;及时性;美国政府;

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1. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements [J] . Annabel Nixon, Cicely Kerr, Katie Breheny, Health and Quality of Life Outcomes . 2013,第2期

机译：癫痫患者的患者报告结果（PRO）评估：根据食品和药物管理局（FDA）法规要求，对癫痫特定PRO的评估
2. 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
3. Recombinant Drug May Be Rationed; Ranbaxy Still in Trouble with FDA; FDA Joins Nanotechnology Review Body; New HPV Tests Approved; FDA Official Reminds Staff to Protect Information; Anti-IL-6 Drug Linked to Deaths; Genentech Withdraws Raptiva Monoclonal Antibody; FDA Finds Problems with Internet Drug Advertisements [J] . Biotechnology Law Report . 2009,第3期

机译：重组药物可按比例分配； Ranbaxy仍在与FDA纠缠； FDA加入纳米技术审查机构；批准了新的HPV测试； FDA官员提醒员工保护信息；抗IL-6药物与死亡有关； Genentech撤回Raptiva单克隆抗体； FDA发现互联网药品广告存在问题
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

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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. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements [O] . Annabel Nixon, Cicely Kerr, Katie Breheny, 2013

机译：癫痫患者的患者报告结果（PRO）评估：根据美国食品药品管理局（FDA）法规要求对癫痫特定PRO的评估
7. PHP92 Serious adverse Drug events reported to the Food and Drug Administration (FDA): analysis of the FDA adverse event reporting system (FAERS) 2006-2011 database [O] . Sonawane K.B., Hansen R.A. 2015

机译：PHP92向食品药品监督管理局（FDA）报告的严重不良药物事件：FDA不良事件报告系统（FAERS）2006-2011数据库的分析

FDA's (Federal Drug Administration) Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies

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