如何查询FDA法规文件的制定历程，背景以及来自各方的评论建议

beiwei5du

1、在FDA制定的各种法规指南等文件中，我们会感兴趣想了解各个利益相关方（监管部门，制药企业以及大众）对于法规，指南文件的相关背景、疑问、建议，了解这些也方便我们制药人士对法规指南能有更深切的理解。从而知其然，并且知其所以然，并在实际日常工作中能充分的做到法规符合性以及实际操作性。
2、那么相应的，我们就需要有了解这些信息的途径，美国的https://www.regulations.gov/就充当了这个信息平台（注：该平台不仅针对于FDA机构的信息发布，其包括所有的美国的联邦机构，比如DOC美国商务部，EPA美国环境署等等）。
3、该平台能查询的文件（document type)包括：Notice、Proposed Rule、Rule、Supporting & Related Material、Other、Public Submission（or comments)，并且若需要更精确的搜索，则可以通过Document Subtype进一步细化文件类型精确查询。
4、除了依据文件类型分类查询外，还可以增加相应的其他条件（比如，"现在仍接受评论"以及"现在评论已关闭"两种类型），即Open for comment选项栏）
5、但是最准确的查询的方式，就是通过Federal Register Number直接查询，因为其是唯一的编号，如2016-19875。查询后会得到“Good Laboratory Practice for Nonclinical Laboratory Studies”这个proposed rule，点击上方的open docket folder进入,可以了解到该proposed rule制定的整个历程中发布的所有primary documents（比如意见征求搞，草案等等），该proposed rule制定的所有背景资料及细节Supporting Documents,以及来自其他利益方（主要是大众和制药企业）对该proposed rule的所有相关评论comments,具体可见：https://www.regulations.gov/#/docket?D=FDA-2010-N-0548。
6、其结果显示大量资料，比如共计收到178个comments，但是仅仅实际上可以查看的为165comments，
主要的原因：Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.
7、那么我们就可以举例下载一个武田制药、无锡药明康德的评论，然后可以仔细研究学习一下了！当然你也可以向该proposed rule提意见，并且提交。

beiwei5du

比如昨天开通的关于复杂药品等相关的指南（draft)已经开始接受评论（其中一个文件已经有相关的评论，正在审查相关的保密信息问题），同时如果想及时了解相应的每个指南文件的来自不同利益方（监管机构，制药企业，大众）的评论动态信息，可以将其与邮箱自动绑定，若有新评论，则邮箱会自动提醒。

Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability

https://www.regulations.gov/#/document?D=FDA-2017-D-5767-0001

Abbreviated New Drug Applications Submissions—Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability

https://www.regulations.gov/#/document?D=FDA-2017-D-5670-0001

Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability
https://www.regulations.gov/#/document?D=FDA-2017-D-5739-0001
Abbreviated New Drug Applications Submissions—Refuse-To-Receive Standards: Questions and Answers; Draft Guidance for Industry; Availability

https://www.regulations.gov/#/document?D=FDA-2017-D-5846-0001

beiwei5du

Instructions for Using Regulations.gov

How to Search for FDA Federal Registers, Dockets and Daily Listings
Find a Migrated Docket

• Go to regulations.gov
• Type the old (legacy) docket number ((ex. 2007E-0001) in the box under the "Search" button and click "Go."
• The 2007E-0001 docket will appear but with a different number: FDA-2007-E-0104
  
  • Remember it will have a different number but it is the same docket
    
• Click on the docket id link
• The old (legacy) docket number will appear in the column Legacy ID
  

Generate Daily Listings (documents entered into FDMS on a given day)

• Go to regulations.gov
• Type "FDA" in the box under the "Search" button and click "Go."
• Then scroll down till you see "Days Since Posted" on the left side of the page, and
• Click "Posted Today."
  

Federal Registers (FR)

• Advance Display: NARA Table of Contents - Advance Display - Public Inspection List (Click on "View Tomorrow's Federal Register)
• Today's FR: Today's GPO Table of Contents
• Historical to Present FRs: GPO Federal Register Database (1994 to present) (Click "Browse" on Left Navigation to browse back issues by year.)
  

Generate a list of the Federal Registers (FR) posted today and open for public comment

• Go to regulations.gov
• Click on Go under More Search Options
• Under Find and Take Action, click on Go under Documents published today and open for public comment
• Click on FDA in the left hand corner
• A list of FR documents will display
  

Submit Electronic Comments for Federal Registers

• Go to regulations.gov
• Click Go under More Search Options
• Click on your preference under Find and Take Action
• Check out "User Tips" for submitting Electronic Comments at regulations.gov
  

More search TipsTo search the Food and Drug Administration (FDA)

• Type FDA in the “Search block” and click “Go>>”. Search displays all dockets and documents that are in the Federal Docket Management System (FDMS) beginning with FDA.
• Click in item to add to your search list that will display results as you move along. To review the items added to your search list see to top right column (“You Searched” [click entry to remove]).
  

“Narrow results” to only FDA:

• Select FDA under the Agency,
• Select More… if FDA does not display,
• Scroll down list to select -FDA and,
• At this point, “Search” results display all Dockets and Documents specific to FDA.
  

“Narrow results”to--DOCUMENT TYPE: (Displays the number of document type from highest to lowest.)

• Supporting and Related Material
• Public Submission
• Notices
• Proposed Rules
• Other
  

*Select one to refine your search list and display results as you more along.

And/Or

“Narrow results”to--DOCKET TYPE: (Displays the number of docket type from highest to lowest.)

• Nonrulemaking - Translates to Notices, Proposed Rules, Petitions, Variance, etc.
• Rulemaking - Translates to Rules and Regulations.
  

*Select one to refine your search list and display results as you more along.

And/Or

“Narrow results”to--COMMENT PERIOD:

• Open
• Closed
  

*Select one to refine your search list and display results as you more along

And/Or

“Narrow results”to--COMMENT PERIOD ENDS: (Choose from the available options.)

Within “3 Days” through “In More Than a Year.”

*Select one to refine your search list and display results as you more along.

And/Or

“Narrow results”to--COMMENT PERIOD STARTED: (Choose from the available options.)

“Comments Started Today” and “In Last 3 Days” through “Older Than a Year.”)

*Select one to refine your search list and display results as you more along.

And/Or

“Narrow results”to:
DAYS SINCE POSTED: (Choose from the available options.)

“Posted Today” and “Last 3 Days through “Last 365 Days.”)

*Select one to refine your search list and display results as you more along.

Additional  Suggestions

Selecting "User Tips" (under "How to Use This Site" on the left-hand side of the Regulations.gov home page) will bring up a list of helpful topics, including new site features and detailed instructions.

Also under "How to Use This Site" is a way to contact the Regulations.gov staff for help.

Go to Regulations.gov
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Page Last Updated: 09/14/2009






补充内容 (2018-3-17 16:12):
中国 http://zqyj.chinalaw.gov.cn/index

胜利者

我的大神！

胜利者

大神能找到ECA guidance Handling of OOE and OOT Results？

beiwei5du

胜利者 发表于 2017-10-5 08:57
大神能找到ECA guidance Handling of OOE and OOT Results？

毛线神，我暂时无法上网，你在Yahoo，Google搜搜！

beiwei5du

beiwei5du 发表于 2017-10-5 09:00
毛线神，我暂时无法上网，你在Yahoo，Google搜搜！

哈哈！

beiwei5du

1、EU的这种平台在哪里查询呢？？？
2、我有了解EU会经常公布一些comments overview,而且会很对于每条建议作出接受还是拒绝的决定（但是这个信息相对于美国的regulation.gov这个平台就相对比较单向性了，而且也会存在滞后性，不便于交流），但是这种决策判定（接受还是拒绝）在美国是在哪里查询呢？？？是否有相应的途径呢？？？？
@roadman @叶非 @一沙一叶

叶非

beiwei5du 发表于 2017-10-8 17:32
1、EU的这种平台在哪里查询呢？？？
2、我有了解EU会经常公布一些comments overview,而且会很对于每条建议 ...

应该是在EMEA的网站上有吧。

套路

楼主辛苦了，感谢分享

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sun12

您好，看到您发的"如何查询FDA法规文件的制定历程，背景以及来自各方的评论建议"，有个问题咨询下，看到FDA的法规例如Part11，有章节会从11.10直接就会变成11.30，中间没有11.20,想咨询下这种情况的原因？

小金库

非常感谢分享