替换
查找内容:
替换为:
全部替换
插入链接
链接网址:
链接显示标题:
请选择网址类型
点我插入链接
插入文件
文件名称:
文件显示标题:
请选择文件类型
点我插入文件
发现错误 发表观点

原文内容

反馈意见

提交 正在提交..... 反馈历史

复制下面的地址分享给好友

确定 正在提交.....
train

你好,

关闭
提交 重做 重新开始 关闭
跳转
  • 新建同级
  • 新建子级
  • 删除
  • 重命名
选择收藏夹
新建收藏夹
公开

取消 确定

1. 基本信息
姓名:
企业:
职位:
联系方式:
邮箱:
2. 请在此填写您的问题,我们将优先安排答疑
提交

报名成功!
课程观看链接如下:
请添加课程助理微信,获得更多信息:
确认
确定
取消 确认

识林

  • 知识
  • 视频
  • 社区
  • 政策法规
    • 国内药监
    • FDA
    • EU
    • PIC/S
    • WHO
    • ICH
    • MHRA
    • PMDA
    • TGA
  • 研发注册
    • 概览
    • 监管动态
    • 研究专题
  • 生产质量
    • 概览
    • 监管动态
    • 各国GMP
    • 中国GMP
    • 中国GMP指南
    • GMP对比
    • 检查缺陷
    • 研究专题
  • 主题词库
  • 帮助中心
  • 关于识林
    • 识林介绍
    • 识林FAQs
    • 功能介绍
    • 团队诊断
    • 联系我们
  • 30天免登录

    忘记密码?

2016年FDA新药批准回顾

首页 > 资讯 > 2016年FDA新药批准回顾

页面比对

出自识林

2016年FDA新药批准回顾
审评
页面比对
笔记

2017-01-04

跳转到: 导航, 搜索

(摘自FDA Voice “A Review of CDER's Novel Drug Approvals for 2016” 2017年1月4日,作者:John Jenkins,医师,美国FDA药品审评与研究中心新药办公室主任)

过去一年是FDA药品审评和研究中心(CDER)新药项目的又一成功年。

CDER审评和批准了22个新药,其中大多数有潜力为成千上万的患有严重和危及生命的疾病的患者增加显著的临床价值。

2016年批准的新药中有首个获批用于治疗脊髓性肌萎缩症患者的新药,首个获批治疗杜氏肌营养不良症的新药,一个治疗某些帕金森病患者幻觉和妄想的新药,另一治疗原发性胆汁性肝硬化的罕见慢性肝病的新药,以及两个治疗丙型肝炎的新药。还有用于治疗卵巢癌、膀胱癌、软组织肉瘤和慢性淋巴细胞白血病的新抗肿瘤药,以及两种用于检测确定形式的癌症的诊断试剂。

这些新药产品中近四分之三(73%)受益于FDA加快药品研发和审评计划(即快速通道认定、突破性治疗认定、优先审评认定和加速批准)。

CDER的审评团队对于95%的2016年获批新药实现了处方药使用者付费法案(PDUFA)规定的目标时限。我们还在“首轮”批准了95%的新药,这意味着不需要将会延迟审批时间和导致其它轮次审评的额外资料。此外,86%的获批新药在获得其他监管机构批准之前在美国率先获批。这些效率的结论是,在继续坚持FDA传统的高批准标准的同时,CDER正在尽快审批药品。

2016年批准的新药总数低于前一年45个新药的批准量,并且低于过去10年间每年29个新药的平均批准水平。这里有几个原因。虽然2015年接收的新药申请数量与最近10年每年35件申请的平均数量相近,但申请提交时间和PDUFA目标日期的自然波动意味着,需要有目标行动的新药申请累积量与近些年相比较少。例如,CDER在2015年批准的5个目标日期在2016年的新药。这些提前批准通过使药品更早上市而使患者受益,但也减少了在2016年获批的新药总量。另一因素是完全回应函(CR)的数量,完全回应函描述了申请中的缺陷,关闭批准同时提出有关申办人需要做什么以支持重新提交申请的建议。CDER在2016年发布了14封完全回应函,高于近年。

在批准之前,每件新药申请必须通过证明新药对于其预定用途是安全有效的并且产品的制造过程是高质量的,以符合法定和监管标准。FDA根据每件申请的自身价值审评。虽然我们报告了面年提交和批准的申请分类,鉴于任何特定申请中包含的数据质量的可预期的变化,批准和CR函的比率往往会逐年波动并不奇怪。在审查2016年向新药签发的CR函中所提及的缺陷时,值得注意的是几件申请的主要缺陷是未能符合FDA现行药品生产质量管理规范(cGMP)的规定。这些法规旨在控制药品制造程序的质量,以确保患者拿到具有一致地高质量的药品,这是药品安全性和有效性的重要组成部分。援引不符合cGMP规定的CR函数量对于单一年份来说异常高。相比之下,从2010年到2015年签发了CR函的47件新药申请中仅有4封CR函包括不符合cGMP作为主要缺陷。2016年可能会提醒申办人,如果他们希望确保申请获批,所有制造设施必须符合cGMP规定。制造设施未能通过FDA检查可能不必要的延误患者获得新药。

年度新药总结提供了更多有关2016日历年CDER新药批准的细节。

个人来说,我将在2017年1月7日从FDA退休,我已在FDA服务将近25年,在联邦政府服务将近32年。我非常荣幸地能与FDA专职公务员共同工作,他们在通常是富有挑战性的情况下的努力工作促进和保护了美国民众和世界各地患者的公众健康。我在FDA期间,我们曾见证了20世纪80年代“药品滞后”(即药品在美国获批之前已在其他国家获批)的消除。今天,超过三分之二的新药在美国FDA率先获批,为美国患者提供了更早获得新药的机会,这些新药可能显著提高其生活质量,并在某些情况下延长其生命。这一显著的变化在不损害FDA批准标准的情况下完成;事实上,在我们在显著提高新药审评计划效率的同时还极大地加强和现代化我们的上市前和上市后药品安全计划。我为自己能够作为帮助FDA成为世界药品监管机构的“典范”而感到自豪。当我离开FDA时,FDA将不会离我而去;FDA的原则和高标准将在我未来的工作中引导我前进。

2017年及以后CDER面临很多新的挑战和令人激动的机遇;我相信新药计划中高度专业和敬业的工作人员将能够应对这些挑战,并且具有经验和远见的将科学上令人兴奋的快速进展转化为患者所需的新的安全、有效的治疗药品。

翻译:识林-椒
识林®www.shilinx.com版权所有,未经许可不得转载。如需使用请联系admin@shilinx.com

A Review of CDER’s Novel Drug Approvals for 2016
Posted on January 4, 2017 by FDA Voice
By: John Jenkins, M.D.

This past year was another successful year for the new drugs program in FDA's Center for Drug Evaluation and Research (CDER).

John JenkinsCDER reviewed and approved 22 novel drugs, most of which have the potential to add significant clinical value to the care of thousands of patients with serious and life-threatening diseases.

Among the novel drugs approved in 2016 were the first treatment for patients with spinal muscular atrophy, the first drug approved to treat Duchenne muscular dystrophy, a new drug to treat hallucinations and delusions in people with Parkinson’s disease, another to treat patients with a rare chronic liver disease known as primary biliary cirrhosis, and two new treatments for patients with hepatitis C. There were also new oncology drugs to treat patients with ovarian cancer, bladder cancer, soft tissue sarcoma, and chronic lymphocytic leukemia — as well as two new diagnostic agents for detecting certain forms of cancer.

Nearly three out of four of these novel products – or 73 percent – benefitted from at least one of FDA’s programs to expedite drug development and review (i.e., Fast Track designation, Breakthrough Therapy designation, priority review designation, accelerated approval).

CDER’s review team also met the goal dates specified by the Prescription Drug User Fee Act (PDUFA) for 95 percent of 2016’s novel drug approvals. We also approved 95 percent of the novel products on the “first cycle,” meaning additional information was not requested that would delay approval and lead to another review cycle. Moreover, 86 percent of the novel drug approvals were approved in the U.S. before they were approved by any other regulatory authorities. The upshot of these efficiencies is that CDER is reviewing drugs as quickly as possible while continuing to uphold FDA’s traditionally high approval standards.

The total number of novel drugs approved in 2016 is lower than the 45 novel drugs approved the year before and below the average of 29 drug approvals per year on average over the last 10 years. There are several reasons for this. While the number of novel new drug applications received for review in 2015 was similar to our most recent 10-year average of 35 applications per year, the natural fluctuation of the timing of application submissions and their PDUFA goal dates, meant there was a smaller pool of novel drug applications to target action on than in recent years. For example, CDER approved five novel drugs in 2015 that had PDUFA goal dates in 2016. These early approvals benefited patients by making the drugs available sooner, but also decreased the total of novel drugs approved in 2016. Another factor was the number of Complete Responses (CR), which describe deficiencies in the application, precluding approval, with advice on what the sponsor needs to do for FDA to support resubmission of the application. CDER issued 14 CR letters for novel drugs in 2016, higher than in recent years.

Each application for a new drug must meet the statutory and regulatory standards for approval by demonstrating that the new drug is safe and effective for its intended use, and that the quality of the manufacturing of the product is high, before it can be approved. FDA reviews each application on its own merits. While we report on groupings of applications submitted and approved each year, given the expected variation in the quality of the data contained in any particular application it is not surprising that the ratio of approvals to CR letters tends to fluctuate from year-to-year. In examining the deficiencies cited in the CR letters issued to novel drugs in 2016 it is notable that the primary deficiency for several of the applications was failure to comply with FDA’s current Good Manufacturing Practice (cGMPs) regulations. These regulations are designed to control the quality of manufacturing procedures for drugs in order to ensure that patients receive drug products of a consistently high quality, which is an important component of the safety and efficacy of a drug. The number of CR letters that cited failure to comply with cGMP regulations was unusually high for a single year. By comparison, only four of the 47 novel drug applications for which a CR was issued from 2010 through 2015, included failure to comply with cGMPs as the primary deficiency. 2016 may serve as a reminder to sponsors that all of their manufacturing facilities must be in compliance with cGMP regulations if they wish to ensure approval of their application. Failure of manufacturing facilities to pass FDA inspection can unnecessarily delay patient access to novel new drugs.

Our annual Novel Drugs summary provides more details about CDER’s novel drug approvals for calendar year 2016.

On a personal note, I will retire from FDA on January 7, 2017, after nearly 25 years of service at FDA and nearly 32 years of service in the Federal government. It has been a great honor and privilege to serve with the dedicated public servants at FDA whose hard work, under often challenging circumstances, serves to promote and protect the public health of Americans and patients around the world. During my time at FDA we have seen the erasure of the “drug lag” of the 1980’s where drugs were approved in other countries years before they were approved in the United States. Today more than two-thirds of novel drugs are approved first by the FDA, providing patients in the U.S. with earlier access to new drugs that have the potential to significantly improve their quality of life, and in some cases to extend their lives. This remarkable change has been accomplished without compromising FDA’s standards for approval; in fact, we have also significantly strengthened and modernized our pre-market and post-market drug safety programs at the same time as we dramatically improved the efficiency of our new drugs review program. I am proud to have been a part of helping to make FDA the “gold standard” for drug regulatory agencies around the world. While I am leaving FDA, FDA will not leave me; its principles and high standards will help to guide me in my future work.

There are many new challenges and exciting opportunities for CDER in 2017 and beyond; I am confident that the highly professional and dedicated staff in the new drugs program will meet those challenges and have the experience and vision to translate the exciting and rapid advances in science into new safe and effective treatments for patients in need.

取自“https://login.shilinx.com/wiki/index.php?title=2016%E5%B9%B4FDA%E6%96%B0%E8%8D%AF%E6%89%B9%E5%87%86%E5%9B%9E%E9%A1%BE”
上一页: 2016年FDA新药审批总结报告
下一页: FDA_12月发布具体产品BE指南摘选点评
相关内容
相关新闻
  • FDA2014年新药审批:为患者雪...
  • 2014年CDER新药审评概况
  • 2019年 FDA新药审批总结
  • FDA预计2016年新分子实体批准...
  • 【全文翻译】2019 年 FDA ...
热点新闻
  • ICH 发布新 Q1 稳定性指南...
  • 【直播】25年4月全球法规月报...
  • 【识林新文章】中国无菌附录对...
  • 【识林新工具】AI知识助手,AI...
  • VHP(过氧化氢蒸汽)的“脆弱...

 反馈意见

Copyright ©2011-2025 shilinx.com All Rights Reserved.
识林网站版权所有 京ICP备12018650号-2 (京)网药械信息备字(2022)第00078号
请登录APP查看
打开APP