FDA仿制药审评展示报告
出自识林
FDA仿制药审评展示报告
笔记 2016-02-08 识林 2月5日上周五，FDA发布一份题为“仿制药审评指示板 – 2016年1月（The Generic Review Dashboard – January 2016 对于那些不熟悉英语商务俚语的人们来说，“dashboard”是一目了然地传递重要动态信息的文件。这个类比想必是与汽车仪表盘相关，汽车仪表盘通常称为“dashboard”，是一目了然地提供关于汽车目前状况的所有必要信息。 仿制药审评指示板的目的似乎是展示未决ANDA（和之前获批申请的补充申请）在等待FDA行动或等待申办人行动期间的状态。OGD工作量简介一瞥的这个想法非常好。清楚地展示了所有已递交但没有最终批准的ANDA处在什么状态。 “当前递交状态简介”分别显示了GDUFA第3年前的申请和所有未批准申请的状态。这些简介数据截至2016年1月1日。图表显示了GDUFA第3年前总共有3470件ANDA仍在等待最终批准，所有未决申请的数量是4105件。分析中没有显示的是这些未决申请已经等待了多久，这是企业非常感兴趣的。许多消息表明，当前中位批准时间是42个月。 行动和审评沟通追踪显示了2015日历年FDA行动的每月详情。大多数人可能不太感兴趣，这部分内容显示了不同类型的沟通。最后，还有一份对人们理解有帮助的关键术语定义列表。建议大家看看这份报告了解FDA仿制药工作的情况。 仿制药审评展示报告链接url 作者：识林-Pepper 英文原文 On Friday February 5th FDA posted a new document titled “The Generic Dashboard Review – January 2016” It says that it is the “first publication” of this analysis, inferring that there will be further issues in the future but not saying how often or when. It states that this analysis is part of OGD's ongoing improvements to “transparency and communication” efforts. For those who may be unfamiliar with English language business slang, a “dashboard” is a document that conveys important status information at a single glance. The analogy is presumably to that of a car instrument panel, usually called the dashboard, which is supposed to provide all the necessary information about the current status of the car at a single glance. The aim of the Generic Review Dashboard seems to be to show the status of pending ANDAs (and Prior Approval Supplements) in term of where they are, that is waiting for FDA action or with the sponsor waiting for sponsor action. The idea of this snapshot of OGD workload at a glance is very good. It clearly shows where all the ANDAs that are filed but not finally approved are. The Current Submission Status Snapshot” shows status for pre-GDUFA Year 3 applications and separately for all unapproved applications. These snapshots are as of January 1, 2016. They show that pre-GDUFA Year 3 there are a total of 3,470 ANDAs still waiting for final approval and for all pending applications that number is 4,105. What this analysis does not show is how long applications have been pending, something that is of great interest to industry. Numerous sources state that the current MEDIAN approval time is 42 months. The Activity and Review Communications Tracking shows the month-by-month detail of Agency actions for calendar year 2015. This is probably of lesser interest to most but dose show the various types of communication. Finally there is a list of definitions of Key Terms which is helpful. The dashboard document can be found at the link below url, and I recommend that you look at it to see what FDA generic drug workload looks likes. 识林®www.shilinx.com版权所有，未经许可不得转载。如需使用请联系admin@shilinx.com |
）”的文件。FDA表示这是分析数据的“首次公开”，推测今后会有进一步的发行物，但没有指出发布频率或发布时间。FDA指出，这项分析是仿制药办公室（OGD）对“透明度和沟通”努力的持续改进。