FDA E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)
标准简介
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)[附网盘链接]是于过去发布的FDA标准，适用于US。标准截图
![E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)[附网盘链接]](/img/20210914103733a2y0r.jpg)
标准文档说明
标准文档类型为E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)[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
E2C(R2) Periodic Benefit-Risk Evaluation (PBRER) 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 create 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 office responsible for this guidance as listed on the title page. 2
I. INTRODUCTION (1) This guidance defines the recommended format and content of a Periodic Benefit-Risk Evaluation Report (PBRER), and provides an outline of points to be considered in the preparation and submission of the PBRER. The PBRER described in this guidance is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions. This guidance revises, combines, and replaces two ICH guidances: E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (ICH E2C guidance) and Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for 3
Marketed Drugs (ICH E2C addendum). 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 the word should in Agency guidances means that something is suggested or recommended, but not required. 1
This guidance was developed within the Efficacy Implementation Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 2012. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States. 2
Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 2012. 3
We update guidances periodically. To make sure you have the most recent version of a guidance, check the Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or the Vaccines, Blood and Biologics Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
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