行业指南：Field Alert Report 提交问答（草案）

beiwei5du

FAR from Reality – Q&A Document Provides Answers to Age Old Questions
By Bob Pollock | July 18, 2018 | Compliance, FDA, Generics, Regulatory Affairs, Science & Technology | 1 |

In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR).  Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.

The draft document, entitled Field Alert Report Submission Questions and Answers Guidance for Industry (here)  provide 31 individual responses to questions from the 6 different general categories listed below:

• What is a FAR and what triggers its submission?
• Who is responsible for submitting the FAR?
• When should I submit a FAR?
• How do I submit a FAR?
• Where do I submit a FAR?
• Should I submit a follow-up or final FAR?
  

The FDA responses cover lots of ground as they tackle many of the areas that have caused industry concern.  For instance, did you know that follow-up and final FARs are not required but it is FDA’s expectations that they will be submitted (see FDA response to 1.b).  The FDA notes that if multiple customer complaints are received, a FAR for each does not have to be submitted if the complaint covers the same issue with product from the same lot(s) identified in the original FAR.

Also of interest is a question as to whether a FAR must be issued for an OOS result or a problem with a lot that has not yet been distributed – the Agency’s answer is NO, if it does not impact other lots in distribution (they note that a FAR is for distributed products only).  Another asks if an OOS result occurs on a distributed batch but the OOS is invalidated within three business days, is a FAR required to be submitted? FDA response, No!  However, another question asks if a corrective action is taken within three business days and the problem is fixed does a FAR need to be submitted – FDA response – Yes!  A little bit of a different situation but an important distinction to make.  Another good one was if a problem involves multiple NDAs or ANDAs, does a separate FAR need to be submitted.  FDA answers Yes, a separate FAR must be submitted to each application.

There are lots of good reading in this draft document.  Please make certain you digest it all before you have a problem or indigestion might not be FAR away.

beiwei5du

其实国内可以建立这种FAR机制，以作为进一步控制相应产品风险的手段。
大家如何认为？？

happygods

beiwei5du 发表于 2018-7-19 06:44
其实国内可以建立这种FAR机制，以作为进一步控制相应产品风险的手段。
大家如何认为？？

你信不信 不出一年 就会有 铜臭在里边？

syhorchid

了解一下

bartonding

thanks for sharing this guidance timely

山顶洞人

beiwei5du 发表于 2018-7-19 06:44
其实国内可以建立这种FAR机制，以作为进一步控制相应产品风险的手段。
大家如何认为？？

我觉得不错，官方不做，民间可以发起！

bartonding

could you provide the guidance to us, then we can use it directly, thanks

beiwei5du

bartonding 发表于 2018-7-19 19:07
could you provide the guidance to us, then we can use it directly, thanks

相关的指南在文章中有链接，望看后大家针对问题可以进行讨论，谢谢！

beiwei5du

山顶洞人 发表于 2018-7-19 19:01
我觉得不错，官方不做，民间可以发起！

这是一种针对于在销产品的报告机制，必定会涉及到相关的监管部门的。

apple5258

FARs是指什么？现场警报？

beiwei5du

apple5258 发表于 2019-3-14 12:53
FARs是指什么？现场警报？

一种对FDA进行通知的途径

罗伊鲱

有翻译稿吗？

补充内容 (2021-9-29 07:37):
https://www.yaozui.com/p/763169

https://www.yaozui.com/p/763167

李尚123

谢谢分享，学习学习