E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance updates the existing E2D guidance entitled "E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting," published in 2003. The draft guidance is intended is to clarify the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs) and update terminology and standards for postmarket adverse event reporting.