五洲医药创新那点事的资讯 - 原研药中的最新动态

评论：FDA正式批准了一种原本用于治疗贫血的铁基药物 ferumoxytol（商品名 FERABRIGHT™）作为脑癌影像学对比剂的新用途

Sun, 11 Jan 2026 14:55:19 +0000

原文来源：https://news.ohsu.edu/2025/12/17/ohsu-research-drives-fda-approval-for-novel-use-of-anemia-drug-in-brain-cancer-imaging

评论：戊二酸咪唑酰胺（vitaglutam）

Wed, 11 Sep 2019 05:27:51 +0000

http://cn.drdoping.com/instructions/Ingavirin/

CDE关于规范电子资料提交文件格式的通知

Tue, 02 Jul 2019 12:38:37 +0000

中心网站申请人之窗电子资料提交栏目于2012年开通，用于接收申请人提交的工艺资料、质量标准、包装标签、说明书等相关电子资料。该栏目对提升审评效率、节约审评人员录入时间、加强与申请人沟通交流、统一电子资料接收途径发挥了积极作用。

随着审评业务开展，电子资料提交的类型、数量不断增加，对数据的安全管理带来一定的挑战和隐患。目前由于申请人使用的OFFICE版本不统一，出现提交的文件后缀为.doc和.docx两个版本，在审评过程中出现了格式变化和乱码等现象，造成了审评时间的浪费，增加了审评勘误率。同时，老版本的WORD文档文件格式标准老旧，在文档管理和保护上存在一定安全风险。为解决上述问题，提高文档安全管理水平，中心网站申请人之窗电子资料提交栏目将不再支持后缀为.doc格式文件的提交，请申请人使用由Microsoft Office或WPS Office生成后缀为.docx格式的文件进行提交，感谢支持与配合。

联系人：数据管理处常江水
联系电话：010-68585566转3520

国家药品监督管理局药品审评中心

2019年7月2日

205000DS INTEGRA DURASEAL MICROMYST APPLICATOR,14cm

Wed, 10 Apr 2019 09:05:07 +0000

评论：如何查全球每个国家的参比制剂？

Thu, 28 Mar 2019 03:36:06 +0000

FDA Announces Guidance on Referencing Approved Drug Products in ANDA Submissions (US)
The FDA announced draft guidance to clarify the use of the reference listed drug, reference standard, and basis of submission in an abbreviated new drug application (ANDA).
by Practical Law Life Sciences
On January 17, 2017, the FDA announced draft guidance entitled Referencing Approved Drug Products in Abbreviated New Drug Application Submissions. Abbreviated new drug application (ANDA) applicants must include a basis of submission that identifies, among other things, the reference listed drug (RLD) and reference standard. The guidance aims to clarify these terms and how to identify them in an ANDA.
Under the guidance:
The RLD is the FDA-approved drug that the applicant seeks to duplicate. The FDA identifies drugs in the Orange Book that are eligible to be RLDs.
The reference standard, which is ordinarily the RLD, is the drug selected by the FDA that the applicant must use to conduct bioequivalence studies. The reference standard may differ from the RLD if the RLD is discontinued or not available in sufficient qualities for testing.
A basis of submission is the statement in the ANDA that includes the RLD. The reference standard, if different from the RLD, should be identified in the bioequivalence sections of the ANDA.
The guidance also addresses:
How an applicant can choose an RLD if the FDA has not designated one or if the applicant intends to refer to a pharmaceutical equivalent to the drug designated as an RLD in the Orange Book.
How an applicant can select a reference standard from those approved by the FDA or request that the FDA select a new reference standard.
How to identify the RLD and reference standard in the ANDA.
Comments on this guidance should be submitted by March 20, 2017.
Source: Federal Register: Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability, January 17, 2017.

全球第一个原研药品查询与搜索，分析的网站

Fri, 22 Mar 2019 15:58:50 +0000

全球第一个原研药品查询与搜索，分析的网站

www.136.org.cn 免费又好用