首页 > FDA标准 > 2017 Guidance

FDA Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry

蒋千琴 10/25/2021 浏览 179 FDA 美国

标准简介

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry[附网盘链接]由FDA于之前发布，适用于美国。

标准截图

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry[附网盘链接]
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry[附网盘链接](截图)

 

标准文档说明

标准文档类型为Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry[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

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides stakeholders information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. Because BsUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible. This guidance describes the types of user fees authorized by BsUFA II, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment. This guidance also describes how FDA determines which products are subject to a fee and discusses certain changes to FDA’s policies under the new law. This guidance does not address how FDA determines and adjusts fees each fiscal year; nor does it address FDA’s implementation of other user fee programs (e.g., 2

Prescription Drug User Fee Amendments, Generic Drug User Fee Amendments). Throughout this guidance, references to user fees or the user-fee program are to the user fee program for biosimilar biological products under section 744H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of 1

This guidance has been prepared by the Division of User Fee Management and Budget Formulation, Office of Management, in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

FDA will publish in the Federal Register the fee revenue and fees resulting from adjustment not later than 60 days before the start of each fiscal year. Section 744H(c)(5) of the FD&C Act, as amended by the FDA Reauthorization Act of 2017.

网盘链接

百度网盘：https://pan.baidu.com/s/1LFm6uctQO4KplBqVOxjk6A
提取码：drr8

【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：41.9472 毫秒

相关评论

相关文章