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GUIDANCE DOCUMENT

Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products July 2024

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2484
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.”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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2484.

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