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。
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.
