GUIDANCE DOCUMENT
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products July 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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
- Docket Number:
- FDA-2024-D-2484
- Issued by:
-
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Drug Evaluation and ResearchOffice 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.”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.