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Urgent Clinical Need

Meaning

Urgent Clinical Need is a regulatory and clinical designation applied to a medical condition or patient population for which existing preventative, diagnostic, or therapeutic interventions are either entirely absent or demonstrably inadequate, resulting in significant morbidity or mortality. This status justifies the expedited development and review of new medical products, such as novel hormonal therapies or diagnostic assays. It prioritizes the deployment of promising innovations to address a severe public health gap.