首页 > FDA标准 > Certain ApplicationsSubmissions

FDA Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff

蒋千琴 12/2/2021 浏览 250 FDA U.S

标准简介

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff[附网盘链接]是Food&Drug Administration于不久前发布的FDA标准，适用于U.S。

标准截图

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff[附网盘链接]
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff[附网盘链接](截图)

 

标准文档说明

标准文档类型为Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain 1

Applications and Submissions to FDA, and FDA Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. This guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the second title page of this guidance. I. INTRODUCTION This guidance document is intended to describe the current thinking of FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) (hereafter, “Center” or collectively, “the Centers”), regarding civil money penalties under section 303(f)(3) of 2

the Federal Food, Drug, and Cosmetic Act (FD&C Act). That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, “submitters”) who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS 3

Act), including its implementing regulations in 42 CFR part 11, to submit clinical trial registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA. The guidance document addresses the following questions: • How do the Centers intend to identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, or whether submitters 1

This guidance has been prepared by the Office of Good Clinical Practice in cooperation with FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Office of Regulatory Affairs. 2

21 U.S.C. 333(f)(3). 3

42 U.S.C. 282(j).

网盘链接

百度网盘：https://pan.baidu.com/s/1XBnbYjft5qfHPh9zpB9zoQ
提取码：fv5h

【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。

加载用时：63.5501 毫秒

相关评论

相关文章