USA – FDA releases draft guidance on use-related risk analysis for combo products

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products. The URRA draft guidance is relevant for drug- and biologic-led combination products, as well as human nonprescription drug products that are part of an investigational new drug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 a...