首页 > 资讯 > 标签变更最终规定已在HHS日程中

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2014-06-19 Lachman CONSULTANTS

卫生与人类服务部发布了其半年一次的监管议程，那么有什么爆炸性新闻呢？对于ANDA持有者可对最新获得的安全性信息进行标签变更，该议程中列出了该拟议规定 。在该拟议行动中，HHS做了如下描述：

该规定将会修订新药申请（NDA）、简化新药申请（ANDA）、生物制品许可申请（BLA）的标签变更法规要求，修改并澄清标签变更的规程，以反映在FDA审评这些变更前获批产品特定类型的最新获得的安全性信息。该规定的描述应能反映如下信息：NDA或ANDA持有者提交的“待批变更（changes being effected, CBE）”标签补充申请应在FDA申请该标签变更过程中向公众开放。

去年2013年11月13日发布的拟议规定，已经引发了各种团体的论战，已经在本博客的之前的数篇博文中提到，全国许多制药行业的团体也对此发出了声音。

大家都知道我会是什么想法，我真的感到非常犹豫不决。对于拟议规定有如此之多的评论提交上来，我在想我们是否能够预判最新的拟议规定中有什么新的东西出来？或者FDA是否会直接就给出一个最终规定？ 面对如潮的评论，FDA是否会考虑这些评论做一些修改？还是FDA想要放手去做而“不理会负面想法，并希望不像所有人想的那么糟糕”？ 请高度关注十二月份，因为我们确信这是FDA可能事实上想要达到的目标日期。

Lachman CONSULTANTS - Bob Pollock先生 2014-06-17
校译：识林-柯 2014-06-19

Label Change Final Rule on the HHS Clock
Written by Bob Pollock • June 17, 2014

The Health and Human Services published its semiannual regulatory agenda and guess what popped up on review? The proposed date of finalization of the Rule on label changes that can be made by an ANDA holder relative to newly acquired safety information is listed as December 2014. In its description of the proposed action, the HHS states:

This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change. This rule would describe the process by which information regarding “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA's review of the labeling change.

The Proposed Rule, which was dated November 13, 2013, has created significant controversy for all type of groups. It has been the subject of multiple previous posts on this blogger’s agenda (here, here, here here, here, here, and here) as well as many pharmacy groups around the country.

You all know how I feel and I appear to be in good company. With so many comments submitted on the Proposed Rule, I wonder if we will get a preview of what is to come in a newly Proposed Rule or if the FDA will go straight to the Final Rule? Will changes be made to take into consideration the outpouring of comments or will FDA try to take the “just ignore the bad idea and hope it isn't as bad as everyone thinks” approach? Keep your eyes peeled in December as we believe this is one target date FDA might actually hit.

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