The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products.
The URRA draft guidance is relevant for drug- and biologic-led combination products, as well as human nonprescription drug products that are part of an investigational new drug application (IND), a new drug application (NDA), or a biologics license application (BLA) or supplements to IND, NDA, or BLA applications. “A URRA is important to help identify use-related hazards associated with the user interface design of the combination product, as well as to characterize risks so they can be mitigated (such as through risk controls) or eliminated through improved product user interface design,” FDA said…
