Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products." This document provides guidance to industry and FDA staff on the purpose and content of a use- related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application.
Abstract as published in the Federal Register.
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