Fed Regist. 1998 Jan 15;63(10):2396-404.
The Food and Drug Administration (FDA) is publishing a guidance entitled "E2B Data Elements for Transmission of Individual Case Safety Reports." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is intended to facilitate the standardization of the data elements for the transmission of individual case safety reports for both preapproval and postapproval reporting periods.
美国食品药品监督管理局（FDA）正在发布一份名为《个体病例安全报告传输的E2B数据元素》的指南。该指南是在人用药品注册技术要求国际协调会议（ICH）的主持下制定的。本指南旨在促进个体病例安全报告在批准前和批准后报告期传输数据元素的标准化。
