Zdrowie i gospodarka · 15.09.2003

International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides definitions associated with postapproval product safety information and standards for collecting and expedited reporting of safety information to the regulatory authorities. The draft guidance is intended to harmonize internationally the collection and management of postapproval product safety data.