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Advances in FDAs Safety Program for Marketed Drugs: Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDAs Center for Drug Evaluation and Research.

机译：FDas安全计划在市场营销中的应用：在FDas药物评估和研究中心建立上市前安全审查和上市药物安全作为平等优先事项。

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FDAs safety assessment of medicines does not diminish after drugs are approved for marketing. Although the premarket phase of study is very intensive, much work still remains to monitor approved drugs over time. No drug is risk-free, and it is not uncommon for new information to be discovered after a drug is on the market and being used by larger numbers of patients. Such information helps provide a better picture of drug risks, enables FDA to give health care professionals and patients the latest information on potential or newly identified risks, and strengthens FDAs ability to safeguard patients against unacceptable risks. In this report, FDA describes the actions CDER has taken in recent years to enhance the quality, accountability, and timeliness of its postmarket drug safety decisions. As a result, FDA now oversees the safety of both innovator and generic marketed drugs with the same rigor and focus as for premarket drug review. These efforts include the development of important new scientific tools to enhance detection of potential drug safety issues that occur once a drug is on the market and new methods for planning, managing, tracking, and communicating about those issues.

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年度 2012
页码 1-20
总页数 20
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Safety program; Marketed drugs; Drug evaluation; Quality; Accountability; Drug safety; Planning; Managing; Tracking;

机译：安全计划;上市药物;药物评估;质量;问责制;药物安全;规划;管理;跟踪;

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专利

1. Post-market drug safety evidence sources: an analysis of FDA drug safety communications. [J] . Chieko Ishiguro, Marni Hall, George A Neyarapally, Pharmacoepidemiology and drug safety . 2012,第10期

机译：上市后药物安全证据来源：FDA药物安全通讯分析。
2. Post-market drug safety evidence sources: an analysis of FDA drug safety communications. [J] . Chieko Ishiguro, Marni Hall, George A Neyarapally, Pharmacoepidemiology and drug safety . 2012,第10期

机译：市场后药物安全证据来源：对FDA药物安全通信的分析。
3. CHANGES IN THE UTILIZATION OF OSTEOPOROSIS DRUGS AFTER THE 2010 FDA BISPHOSPHONATE DRUG SAFETY COMMUNICATION: AN EVALUATION OF THE US MEDICAID PROGRAM [J] . Balkhi B., Seoane-Vazquez E., Rodriguez-Monguio R., Osteoporosis international: a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA . 2016,第Suppla1期

机译：2010年FDA双膦酸盐药物安全通信后骨质疏松药物使用的变化：对美国医学计划的评估
4. COMMUNICATION OF DRUG HAZARD INFORMATION:A CRITICAL ANALYSIS OF THE RELATIONSHIP BETWEEN THE PHARMACEUTICAL INDUSTRY, FDA, CLINICIANS, AND PATIENTS AND THE IMPACT ON PATIENT SAFETY [C] . Alison G. Vredenburgh, Matthew B. Weinger Proceedings of the Human Factors and Ergonomics Society 48th annual meeting (HFES 2004) . 2004

机译：药物危害信息的传播：对制药业，FDA，临床医生和患者之间关系以及对患者安全影响的关键分析
5. The Food and Drug Administration's new drug approvals and market withdrawals for safety under the Prescription Drug User Fee Act and the Food and Drug Modernization Act. [D] . Dziurzynski, Bogdan. 2005

机译：食品和药物管理局根据《处方药使用者费用法》和《食品和药物现代化法》为安全起见批准了新药，并撤出了市场。
6. Ten-Year Experience for the Center for Drug Evaluation and Research Part 2: FDA’s Role in Ensuring Patient Safety [O] . Jonathan P. Jarow, Steven Lemery, Kevin Bugin, -1

机译：药物评估和研究中心的十年经验第2部分：FDA在确保患者安全方面的作用
7. Theme III: does the FDA approval process for antihypertensive agents assure efficacy, safety and timeliness? Does the FDA approval process for antihypertensive drugs assure efficacy, safety and timeliness? The public health perspective. [O] . B PSATY 1999

机译：主题III：FDA批准过程是否有助于抗高血压药剂来确保疗效，安全性和及时性？ FDA是否批准抗高血压药物的批准过程确保疗效，安全性和及时性？公共卫生视角。

Advances in FDAs Safety Program for Marketed Drugs: Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDAs Center for Drug Evaluation and Research.

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