首页 > 资讯 > 两份与仿制药行业密切相关的指南草案延长评议期

出自识林

2013-11-26 Lachman CONSULTANTS

FDA对两份与仿制药行业密切相关的指南草案延长两周评议期

11月27日将公布两份关于独立的指南草案文件联邦公告，延长14天评议期。此前因Regulations.gov网站技术故障，使得11月4-13日一些留言者无法电子提交各自的备案。

丙酸氟替卡松，沙美特罗生物等效性指导的行业指南草案（FR notice）和2012年仿制药使用者付费：问答（修订1）行业指南草案（FR notice）的评议文件将继续额外开放两周以收集意见。

这两份指南草案文件均会解决仿制药行业的显著问题，因此，如果您仍有意见提出，您的机会之窗仍然开放。

现在评议
丙酸氟替卡松，沙美特罗生物等效性指导的行业指南草案：指南草案，评议链接
2012年仿制药使用者付费：问答（修订1）行业指南草案：指南草案，评议链接

FDA to Extend Comment Period on Two Issues for Two Weeks
Written by Bob Pollock • November 26, 2013

Two Federal Register notices that will both publish on November 27, 2013, extend the comment period for 14 days on two separate Draft Guidance documents, due to technical problems that occurred on the Regulations.gov website that made it impossible for some commenters to make electronic submissions to the respective Dockets from November 4-13, 2013.

The Dockets will stay open for an additional two weeks to receive comments on the Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate (see FR notice here) and the Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1) (see FR Notice here).

Both of these Draft Guidance documents address significant issues for the generic drug industry, so, if you still have comments to make, your window of opportunity is still open.