20160113 ECA新闻：FDA公布2份IND指南草案征求意见

20160113 ECA新闻：FDA公布2份IND指南草案征求意见

GMP News
13/01/2016

FDA publishes two Draft IND Guidances for Comments

FDA公布2份IND指南草案征求意见

In December 2015 the Food and Drug Administration (FDA) published two draft guidances relating to investigational new drug applications (INDs). Comments and suggestions regarding the draft documents should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

2015年12月，FDA公布了2份与IND有关的指南草案。相关意见和建议应在草案在联邦注册公布起60天内提交。

The draft guidance "Best Practices for Communications Between IND Sponsors and FDA During Drug Development - Guidance for Industry and Review Staff" was published on December 4, 2015. Additionally, a second draft guidance "Safety Assessment for IND Safety Reporting - Guidance for Industry" was published on December 16, 2015.

指南草案“行业和审核人员指南---药品研发期间IND发起人和FDA之间的最优沟通规范”在2015年12月4日公布。另一份指南草案“行业指南----IND安全性报告的安全性评估”在2015年12月16日公布。

The draft guidance on "Best Practices for Communications Between IND Sponsors and FDA During Drug Development" describes

指南草案“行业和审核人员指南---药品研发期间IND发起人和FDA之间的最优沟通规范”描述了：

• FDA?s philosophy regarding timely interactive communication with IND sponsors as a core activity;
• FDA关于与IND发起人及时相互沟通作为核心活动的理念
• The scope of appropriate interactions between review team and sponsor;
• 审核组和发起人之间适当互动的范围
• The types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program;
• 在其药品研发期间，发起人向FDA寻求建议类型
• General expectations for the timing of FDA response to IND sponsor inquiries;
• FDA给IND发起人的询问回复时间限度的一般预期
• Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development;
• 药品研发期间促进FDA审阅团队和IND发起人之间互动的最佳规范和沟通方法
• Expectations for appropriate methods, including the frequency, of such communications.
• 这类沟通适当方法的预期，包括频次
  

The draft guidance emphasizes that during the IND phase of drug development (e.g. time during which human trials of investigational drugs are conducted) "each year, sponsors and FDA engage in thousands of formal and informal communications, including meetings and teleconferences". Therefore, "it is important that interactions be conducted efficiently and consistently, with clear, concise and timely communication".

指南草案强调了药品研发的IND阶段（例如，临床前药品人体试验进行期间），“每年，发起人和FDA进行数千起正式和非正式沟通，包括会议和电话会议”。因此，“清楚、简洁、及时有效持续地进行互动是非常重要的”。

In general "complex scientific/technical, policy, or regulatory questions are best posed to FDA in either requests for formal meetings or in formal submissions". Timelines for FDA sending feedback to sponsors via the formal meeting process are described (among others) in FDA guidances and submissions often have regulatory-mandated timelines for reviewing and providing feedback to sponsors that are described by statute or regulation. For all other sponsor inquiries, (via telephone, email, or in a submission), that include specific questions for which sponsors are seeking FDA feedback, FDA strives to acknowledge such communications within 3 business days of receipt. Similarly, sponsors should acknowledge receipt of FDA?s information requests and provide FDA with an estimated response time.

一般来说“复杂科学/技术、原则或法规问题最好在正式会议或正式申报中提交询问”。FDA通过正式会议流程回复发起人的时间限在FDA指南中进行了描述（与其它一起），申报通常有法规强制的审核和回复时间限，在法规中进行了规定。对发起人所有其它询问，（通过电话、电子邮件或申报）包括发起人寻求FDA回复的特殊问题，FDA将尽力在收到后3个工作日内发出收条。同样，发起人应给FDA的信息索取发出收条，向FDA提交预期的回复时间。

The following "best practices and communication methods" are outlined in the draft guidance:

指南草案中列出了以下“最佳规范和沟通方法”：

• Meetings between FDA and sponsors;
• FDA和发起人之间开会
• Written correspondence from FDA;
• FDA发出书面信函
• Submissions from Sponsors;
• 发起人提交
• Acknowledging receipt of communications;
• 沟通收条
• Email between FDA and sponsors;
• FDA和发起人之间的电子邮件
• General telephone calls between FDA and sponsors;
• FDA和发起人之间常规电话
• Faxes between FDA and sponsors;
• FDA和发起人之间发传真
• Use of Out-of-Office Messages by FDA and sponsors;
• FDA和发起人使用办公室外信息
• Resources for sponsors.
• 发起人可用资源
  

Additionally, in certain limited circumstances, sponsors can directly contact one of the FDA?s resources listed in section "Additional Contacts" of the draft guidance. For further information, please find all the details in the Draft Guidance "Best Practices for Communications Between IND Sponsors and FDA During Drug Development".

此外，在某些受限情况下，发起人可以直接联系FDA列在指南草案“额外联系人”上的FDA资源中的联系人。更多信息参见指南草案。

The second draft guidance "Safety Assessment for IND Safety Reporting - Guidance for Industry" provides "guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND". The guidance is a follow-on to the guidance Safety Reporting Requirements for INDs and BA/BE Studies and is most applicable to sponsors managing a drug development program that has multiple studies. During the evaluation of comments to the draft guidance Safety Reporting Requirements for INDs and BA/BE Studies and at meetings with stakeholders, FDA identified the need for additional guidance on IND safety reporting. The draft guidance contains recommendations on:

第二份指南草案“行业指南----IND安全性报告的安全性评估”给“发起人提供关于人药和兽药临床前新药申报（IND）安全报告系统研发方法指南”。指南是对指南“IND和BA/BE研究的安全报告要求”的后续指南，最适用于管理多个研究的药品研发项目的发起人。在指南草案“”意见评估期间，以及在与干系人会议期间，FDA说明了需要另一份关于IND安全性报告的指南。该指南草案含有以下方面的建议：

• Composition and role of a safety assessment committee;
• 安全性评估承诺的内容和作用
• Aggregate analyses for comparison of adverse event rates across treatment groups;
• 不同治疗组之间不良事件比较汇总分析
• Planned unblinding of safety data;
• 计划的安全数据揭盲
• Reporting thresholds for IND safety reporting;
• IND安全报告的报告阀值
• Development of a safety surveillance plan.
• 安全性监管计划建立
  

More information can be found in the draft guidance "Safety Assessment for IND Safety Reporting - Guidance for Industry".

更多信息在指南草案中可以找到。

http://zhuyujiao1972.blog.163.com/blog/static/9869472720160142116690/