Stakeholders want the US Food and Drug Administration (FDA) to provide more clarity on its expectations for use-related risk analyses (URRA) for “stand-alone” non-combination medical products. They also called for more alignment with the agency’s human factors guidance and ISO standards.
In July, FDA requested comment on it URRAs for drug and biologics-led combination products and nonprescription drug products that are part of an investigational new drug application (IND), a new drug application (NDA), a biologics license application (BLA) or a supplement to these applications. While the guidance is geared toward combination products, it states that it may also apply to certain “stand-alone” prescription or non-prescription drugs. (RELATED: FDA releases draft guidance on use-related risk analysis for combo products, Regulatory Focus 9 July 2024)…
