By Fran DeGrazio, executive editor
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2024 was an exciting year for newly released FDA guidances. Among those regulatory documents garnering significant attention was the Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, released in July. This draft guidance on conducting a URRA (Use-Related Risk Analysis) was especially welcomed and needed, as deficiencies in URRAs have been reported as a leading cause of delays with FDA submissions.
During product development, a URRA is a tool used to identify hazards related to product use and to include specific focus on those hazards in documentation provided to the FDA as part of the regulatory review and approval process.
In November 2024, I had the pleasure of moderating a Drug Delivery Leader Live! event, Human Factors Risk Analysis: Leveraging URRA And uFMEA Tools, designed to raise awareness and understanding of the FDA URRA guidance. Joining me and Drug Delivery Leader Chief Editor and event co-host, Tom von Gunden, were SMEs (subject matter experts) Shannon Hoste, Chief Scientific Officer at Pathway for Patient Health, and Natalie Abts, who leads human factors work at Genentech.
Key topics from the event intended to help biopharma organizations in determining when and how to implement a URRA included the following:
- URRA and uFMEA comparison
- URRA documentation
- URRA and IFU relationship
URRA And uFMEA: Two Tools To Leverage
In addition to the URRA, there is an additional tool also commonly used in conducting risk analysis for new products, the User Failure Modes & Effects Analysis, or uFMEA. A uFMEA is typically utilized by engineers during development activities. A developer would identify the product usage steps and identify which tasks are most likely to result in errors. These areas would have the highest priority for mitigating risk by redesign, labeling, or visual prompts, as examples. Given the thoroughness of the detail often documented in a uFMEA, the information gleaned from it may helpfully form the basis for the URRA, if used selectively and judiciously (more on that below). In the Live! event, panelist Natalie and Shannon offered illustrations and suggestions about using a uFMEA, including in conjunction with or as an input to a URRA.
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2024 was an exciting year for newly released FDA guidances. Among those regulatory documents garnering significant attention was the