首页 > 资讯 > FDA延长药品生产商标签安全性信息更新拟议评议期

出自识林

2013-12-20 FDA

FDA延长品牌药和仿制药生产商标签安全性信息更新（“变更待批”补充拟议）拟议的评议期

摘要：
[12月18日] FDA决定对“已获批药品和生物制品标签说明变更补充申请拟议”(“变更待批”补充拟议）延长60天评议期。该拟议法规的评议期将被延长至2014年3月13日，根据《1995年减少公文法》规定的信息收集相关问题评议期将延长至2014年2月11日。评议期的延长响应了利益相关人士提供额外时间提交意见的请求。

该拟议法规相关评论，请见：
【仿制药公司雪上加霜，需上报不良反应 识林资讯】，【GPhA要求延长标签规定拟议的评议期 识林资讯】

提交意见请登录http://www.regulations.gov ，查找备案号FDA-2013-N-0500。

FDA to Extend Comment Period on Proposed Rule on Safety Labeling Updates By Brand and Generic Drug Manufacturers (“Changes Being Effected” Supplements proposed rule)

[12/18/2013] FDA has decided to extend the comment period by 60 days for the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" ("Changes Being Effected" Supplements proposed rule). The comment period on the proposed rule will be extended to March 13, 2014, and the comment period on information collection issues under the Paperwork Reduction Act of 1995 will be extended to February 11, 2014. This extension is being provided in response to requests to provide interested persons with additional time to submit comments. FDA is expediting publication of a notice in the Federal Register to extend the comment period.

In the Federal Register of November 13, 2013, FDA published a proposed rule with a 60-day comment period to request comments on the proposal to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. Comments on the proposal to permit holders of abbreviated new drug applications to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug upon submission of a "changes being effected" supplement will inform FDA's rulemaking.

Submit comments electronically to the FDA docket on http://www.regulations.gov, use docket number FDA-2013-N-0500.

To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

原文请见 FDA to Extend Comment Period on Proposed Rule on Safety Labeling Updates By Brand and Generic Drug Manufacturers